STATE OF MINNESOTA AND BLUE CROSS AND BLUE SHIELD OF MINNESOTA,
PLAINTIFFS,
V.
PHILIP MORRIS, INC., ET. AL.,
DEFENDANTS.
TOPIC: TRIAL
TRANSCRIPT
TRANSCRIPT OF PROCEEDINGS
DOCKET-NUMBER: C1-94-8565
VENUE: Minnesota
District Court, Second Judicial District, Ramsey
County.
YEAR: February
23, 1998
A.M. Session
JUDGE: Hon. Judge Kenneth J. Fitzpatrick, Chief Judge
THE CLERK: All rise. Ramsey County District Court is now in session,
the
Honorable Kenneth J. Fitzpatrick presiding.
(Jury enters the courtroom.)
THE CLERK: You may be seated.
THE COURT: Good morning.
(Collective "Good morning.")
THE WITNESS: Good morning, sir.
THE COURT: Good morning.
All right, counsel.
MR. WEBER: Thank you, Your Honor.
Good morning, ladies and gentlemen.
(Collective "Good morning.")
JAMES F. GLENN called as a witness, being previously
sworn, was
examined and testified as follows:
BY MR. WEBER:
Q. Good morning, Dr. Glenn.
A. Good morning, Mr. Weber.
Q. Dr. Glenn, when we stopped last Friday, we had
discussed your
background and credentials, the organization of the CTR, and the membership
of the Scientific Advisory Board. Do you remember?
A. Yes.
Q. I want to start today discussing the research
grant program of the
Scientific Advisory Board, and the first question I'll have for you
is
whether the CTR over the years has published reports summarizing the
research activity of its grantees?
A. Yes, sir. There has been an annual report since
the very beginning
of -- of CTR, or TIRC. The annual report embraces policy statement,
introduction, summary of activities of the preceding year, and then
abstracts of all of the articles published by investigators who were
supported by CTR during that year, and finally an index of all
investigators in the current volume and all prior investigators.
MR. WEBER: Your Honor, may I approach the witness
with this set of
exhibits?
(Box of documents handed
to the witness.)
Q. Dr. Glenn, I know you've looked through that
box before. Would you
confirm that that includes originals or copies of the annual reports
of The
Council for Tobacco Research?
A. Yes. These are -- are typical annual reports
of CTR.
MR. WEBER: Your Honor, let me hand up Exhibit 50002,
and at this time I
would move the admission through Exhibit 50002 of the annual reports
of The
Council for Tobacco Research.
MR. CIRESI: We have no objection, Your Honor, subject
to verification
that each exhibit relates to the specific annual report.
THE COURT: Are you going to read through all those,
counsel?
MR. CIRESI: I don't think so, Your Honor. I think
I'll just check to
make sure the year is the same as the number.
*2 THE COURT: Court will receive 50002.
BY MR. WEBER:
Q. Dr. Glenn, would you turn to Exhibit MD000084,
which is one of the
CTR annual reports. I believe it's the 1992 annual report.
A. Yes, sir.
Q. And using the 1992 annual report, I'd like you
to describe briefly
for the jury the contents of an annual report.
First of all, sir, is that the typical format for
a CTR annual report
during your tenure at CTR?
A. Yes.
Q. Now could you hold up the annual report for 1992
to the ladies and
gentlemen of the jury so they could see what we're talking about.
A. (Witness complies.)
Q. Thank you.
Now inside the front cover, Dr. Glenn, is a document
called
"Organzation and Policy." Correct?
A. Yes.
Q. And could you --
Is there anything in the organization and policy
you'd like to function
-- or to mention specifically to the ladies and gentlemen of the jury?
A. Well I think there are several important points
here: it dates our
origin back to 1954; it states that our support is from the tobacco
manufacturers, growers and warehousemen; states that the program has
been
one of grants-in-aid, which is research grants, supplemented by contracts
for research with institutions and laboratories; states that the council
does not operate any research facility; states that the Scientific
Advisory
Board meets regularly to judge the grant applications; and it states
that
the council awards research grants to independent scientists who are
assured complete scientific freedom in conducting their studies, and
the
grantees are responsible for reporting or publishing their findings
in the
accepted scientific manner.
Q. Dr. Glenn, could you continue to the table of
contents page.
A. Yes, sir.
Q. Bring that up just a little, if you could. Okay.
Now does this describe the -- or set forth what's
contained within the
annual report?
A. Yes, it does.
Q. Now it refers in the -- two of those early lines
to abstracts. Do
you see that?
A. Yes.
Q. What is an abstract in the scientific literature?
A. Well the abstract is a summary of a paper, and
virtually every
journal requires that there be an abstract paragraph by the authors
of the
study. The abstract details the reason for the research, the methods
used
in the research, the results and the author's conclusions from those
results. Those abstracts are published with the paper. We simply take
the
abstract from the paper and use it as a report in the -- in the journal.
Q. So the abstracts that are reprinted in the CTR
annual report are
simply reprints of abstracts from the scientific literature.
A. Yes.
Q. And down at the bottom of this table of contents,
does it show in
each annual report a list of all active projects?
A. Yes, sir.
Q. And does it have a list of all completed projects
over the years?
A. Yes, sir.
Q. And does it have an index of the principal investigators
over the
years?
A. It does.
Q. Could you turn, Dr. Glenn, to the introduction
page.
*3 A. Yes.
Q. Now as of 1992, approximately 204 million dollars
had been spent in
the council's research program; correct?
A. That's correct.
Q. Now it talks -- if we go down to the next paragraph
that begins
"Eighty- three...," could you read that paragraph to the ladies and
gentlemen of the jury.
A. "Eighty-three original projects were approved
in 1992; many more
continuing and renewal studies also were funded. To date, a total of
1,329
original investigations have been reported -- supported by the council.
Recipients for these are 932 independent scientists at more than 300
medical schools, hospitals and research centers."
Q. Now the next paragraph, Dr. Glenn.
A. "Council grantees published 342 reports on their
supported research
during the year. Abstracts of these are included in this report. The
total
for such publications now is at least 4,770."
Q. Now has that number grown for published reports
since 1992?
A. Yes, incrementally each year.
Q. Now could you turn, I believe, to the next page,
Dr. Glenn -- or
excuse me, go to page 21, if you would, please.
A. Yes, sir.
Q. And that page at the top is entitled "Abstracts
of Reports?"
A. Yes, sir.
Q. And that begins the reprints of the abstracts,
and they're broken
down by subject matter; correct?
A. Correct.
Q. And the first one, just as an example, I'd like
you to focus on is
this one which relates to the first in a series of cancer-related studies.
A. Yes, sir.
Q. Now are they listed --
Are the abstracts listed alphabetically by the name
of the grantee?
A. Yes, they are.
Q. Now this first one that's -- the beginning of
which is "Malignant
Epithelial Cells," do you see that?
A. Yes, sir.
Q. Down at the bottom, does that indicate who the
grantee is?
A. Yes. This was Dr. Harry Antoniades, who was a
professor at Harvard
University Medical School.
Q. Now --
And then does the next line advise as to where this
research was
published?
A. It was published in the Proceedings of the National
Academy of
Sciences in May 1992.
Q. Is the National -- Proceedings of the National
Academy of Sciences
one of the most prestigious scientific journals in the world?
A. Yes, sir.
Q. Have SAB members over the years been members
of the National Academy
of Sciences?
A. Yes, sir.
Q. Now was this research grant here supported by
funding from any other
research institute?
A. It is noted that other support in addition to
CTR was from the
National Institutes of Health.
Q. Now when CTR reprints these abstracts and talks
about other support,
where do they get the information as to who else has funded this research?
A. This comes from the paper itself. The investigators
will have a
footnote on the paper that says support for this research work came
from
the following sources, and it may say CTR grant number such and such,
may
say NIH and give the grant number, may say American Heart, American
Lung,
or whatever the source of other funding may be. Sometimes there are
several
sources.
*4 Q. Now does this reprinting of abstracts continue
by category
throughout the report?
A. I'm sorry, Mr. Weber?
Q. Does the reprinting of the abstracts by category
continue throughout
the report?
A. Yes, sir.
Q. Could you turn back to the table of contents
for a moment, Dr.
Glenn.
A. Yes, sir.
Q. And does that show that there are approximately
26 pages of
abstracts on cancer-related studies?
A. Yes, sir.
Q. And approximately 14 on the respiratory system?
A. Yes, sir.
Q. Approximately 36 on heart and circulation?
A. Yes.
Q. Approximately ten on neuropharmacology and physiology?
A. Yes.
Q. And approximately 103 on pharmacology, biochemistry
and cell
biology?
A. Yes.
Q. And approximately 28 on immunology and adaptive
mechanisms?
A. That's correct.
Q. And when listing the active projects, is that
approximately 24 pages
to list?
A. Yes.
Q. And completed projects, about 25 pages or so?
A. Yes, sir.
MR. CIRESI: Your Honor, all the questions are leading,
and I don't know
if this is preliminary, going to something, but I'm going to object
to the
leading nature of the questions.
THE COURT: Well they are leading, but I consider
it just preliminary.
BY MR. WEBER:
Q. Now let's discuss how the grant process works
that leads to the
funding of this research, if we could, Dr. Glenn.
When the SAB approves an application and advises
The Council for
Tobacco Research that it should be funded, is the funding provided
directly
to the researcher?
A. No, no. The funding goes to the institution in
which the
investigator is employed. The responsible fiscal authority for the
grant
will be the institution. For example, with the grant to Dr. Antoniades,
the
grant in that case, I think, was to the Harvard School of Public Health,
and they are responsible for reporting on expenditure of funds.
Q. When a researcher applies for a grant, what are
they advised as to
the policy of the CTR as to publication of research results?
A. Well they're universally advised that they are
encouraged to publish
their results, and specifically to report in accepted peer-reviewed
journals.
Q. Is the application for a grant a two-step process,
doctor?
A. Yes, sir.
Q. Could you describe that.
A. Well generally an investigator will learn of
CTR as a source from
one of its colleagues or perhaps at a medical meeting where someone
mentions support by CTR. They then will contact us by telephone or
by
letter, and we have response to them that indicates that we would like
to
see a preliminary proposal, which would be a two- or three-page letter,
not
in great detail or great depth. That preliminary inquiry, then, is
circulated to members of the Scientific Advisory Board, and if they
feel
like it's within our area of interest; that is, a project that we would
want to support, then the investigator is so advised and encouraged
to
develop the full grant application, which sometimes may run to 20 or
30
pages. So it's quite a bit of work to put together a grant application.
*5 In that application, that second application,
the final application,
they will detail the project, they will give a bibliography of background
information that's necessary to develop their -- their thesis, they
will
tell us of the methodology they intend to use, they will tell us who
else
will be involved in the project, they'll provide a brief resume of
their
own credentials and those -- and the credentials of the others who
work
with them, and then finally they will present us with a budget for
the
project, detailing how they would expend the funds that they're requesting.
Q. Dr. Glenn, could you briefly outline for the
jury the criteria
applied by the SAB when they receive a final application.
A. Well I think the first criterion, of course,
is merit, is this
project worthy of support in the -- in the view of the scientists who
do
the review? Secondly, I think they would consider whether this is --
will
add to the general body of knowledge in the particular field. I think
they
also consider its relevance to issues of smoking and health; that is
to
say, is this a fundamental problem that will shed light on the fundamental
disease processes that are going on in those diseases that are
statistically associated with smoking? They will look clearly at the
qualifications of the investigator. They look at the quality of the
institution from which the application comes. They make certain that
the
laboratory facilities and equipment are available and appropriate to
the
study that's being proposed. And I think those -- that covers generally
the
field that they would examine.
Q. During your tenure at the CTR, has the Scientific
Advisory Board
discussed factors such as legal implications, public relations
implications, or whether the companies themselves would approve or
not
approve of the research?
A. No, sir.
Q. Is the Scientific Advisory Board in fact an Advisory
Board?
A. It is.
Q. How -- how does that work?
A. Well obviously the final decision about the amount
of funding is
left to our staff and the administrative process. The Scientific Advisory
Board ranks the grant applications according to the criteria we've
discussed. This ranking is a numerical ranking. Each member of the
SAB
votes on a scale of one to five. Clearly we can develop a -- an average
score for each grant application that gives us a ranking system. The
staff
then accepts the recommendations of the Scientific Advisory Board and
may
make adjustments to budget. For example, if an investigator requests
a very
expensive piece of equipment and in our view this is something that
the
institution ought to undertake because it's going to be a long-term
acquisition for them, then we may say please send us a revised budget
indicating deletion of this particular piece of equipment, and the
investigators will almost universally respond in that way.
Q. Is there anyone who votes on the rankings other
than the SAB
members?
A. No, sir.
Q. Are you aware of a committee that was in existence
at one time known
as the Industry Technical Committee?
*6 A. Yes, sir.
Q. What was --
What's your understanding of what the Industry Technical
Committee was?
A. The Industry Technical Committee, I think --
I -- I've never met
with them or talked to them about this, but I think --
MR. CIRESI: Objection, it calls for speculation
and conjecture.
MR. WEBER: I'll lay some foundation.
THE COURT: You'll have to lay some foundation, counsel.
BY MR. WEBER:
Q. Given your experience at The Council for Tobacco
Research, have you
come to gain an understanding from its records and from the meetings
you've
attended as to what was the Industry Technical Committee?
A. I have.
Q. Could you explain that, sir.
A. Industry Technical Committee --
MR. CIRESI: Excuse me.
A. -- was made up of representatives --
MR. CIRESI: Excuse me, doctor. Excuse me. There
still is no foundation.
I don't know what documents he's referring to.
THE COURT: Can you give us a little more, please.
BY MR. WEBER:
Q. Dr. Glenn, have you, during your tenure at CTR,
met with an
individual who was a representative of the Industry Technical Committee?
A. I have met representatives of the Industry Technical
Committee, yes.
Q. Did industry -- members of the Industry Technical
Committee at any
time attend meetings of the Scientific Advisory Board?
A. In my early tenure with CTR, the Industry Technical
Committee would
send one representative to each meeting.
Q. And have you come to understand about whether
the Industry Technical
Committee would attend meetings of the SAB in prior years?
A. As I understand it, they did.
Q. Can you explain to me what your understanding
is of the Industry
Technical Committee?
MR. CIRESI: Your Honor, I'm going to object, again,
because now he says
that they attended, and just before, at --
"Question: What was your understanding of what the
Industry Technical
Committee was?
"The Industry Technical Committee, I think -- I
-- I've never met with
them or talked to them about this, but I think --"
And now he says that they were at meetings where
he was at. There's
still no foundation.
THE COURT: All right.
MR. WEBER: May I be heard?
THE COURT: Yes.
MR. WEBER: I mean he's made it clear that he said
he never met with the
whole committee, but he has met with representatives of the committee.
They
have attended meetings. He has a first-hand understanding of why they
were
there, and that's all I'm asking for, is him to explain that.
THE COURT: Okay. Are you going to be asking questions
about their
attendance at these meetings here?
MR. WEBER: Yes.
THE COURT: Okay. Go head.
BY MR. WEBER:
Q. What was your understanding as to the role that
a representative of
the Industry Technical Committee played at meetings of the Scientific
Advisory Board?
A. The representative who came to the meetings was
there only as a
consultant in case any question arose as to research that was being
accomplished by the industry, or to answer technical questions, usually
of
a chemical nature.
*7 Q. Did any member of the Industry Technical Committee
ever vote on a
grant application?
A. No, sir.
Q. Did company scientists ever vote on grant applications?
A. No, sir.
Q. By the way, would outside scientists from the
public health
community be invited from time to time to attend SAB meetings?
A. Yes.
Q. Can you explain that.
A. Well the CTR intended to maintain contact with
the general
biomedical research community and with public health officials, and
frequently there would be representatives from the American Heart
Association, American Cancer Society, the NIH, particularly the National
Cancer Institute, who would join the meetings. Not at voting members,
but
simply to be there for technical consultation if required.
Q. You mentioned NIH, Dr. Glenn.
A. Yes, sir.
Q. National --
That's National Institute of Health?
A. Yes.
Q. Now in addition to the grant process, did CTR
sometimes fund
research by contract?
A. Yes, sir.
Q. Was the contract research approved by the Scientific
Advisory Board?
A. Yes.
Q. Was it part of the Scientific Advisory Board's
research program?
A. Yes.
Q. Do other funding institutions use contracts occasionally
as well to
fund research?
A. Yes. I think virtually every funding organization
uses the contract
mechanism, including agencies of the federal government, and the reason
is
that generally the contract research that's -- that is specified is
of such
magnitude, such size, that one single laboratory or independent
investigator probably couldn't -- couldn't manage it himself. So the
contract work was usually limited to bigger projects.
Q. And does the National Institute of Health use
contract research?
A. Yes.
Q. How does the amount of funded research that went
through the SAB
program break down between grant research and contract research?
A. I've forgotten the exact figures, but I -- I
think currently -- or
in 1994 the amount of contract research would constitute less than
five
percent of the total budget.
Q. So the vast majority has been the grant program.
A. Yes.
Q. Dr. Glenn, what is CRT's policy regarding the
publication of
research results undertaken by researchers that the CTR SAB has funded?
A. Policy is that the -- as stated in the policy
statement --
investigators are encouraged to present and publish their results in
the
usual and accepted scientific manner.
Q. Have the results of CTR-funded research appeared
in leading
scientific journals throughout the world?
A. They have.
Q. Could you turn to tab 13, Dr. Glenn, and that
is Exhibit AM000204.
A. Yes, sir, I have that.
Q. And can you identify that as a listing of journals
and publications
in which CTR research has appeared?
A. I can, yes.
MR. WEBER: Your Honor, I'd move the admission of
Exhibit AM000204.
MR. CIRESI: No objection, Your Honor.
THE COURT: Court will receive AM000204.
BY MR. WEBER:
Q. Now Dr. Glenn, that list is approximately 29
pages long?
*8 A. It is.
Q. Let's start with U.S. journals and just go through
a few briefly.
Has research funded through the SAB appeared in
the Journal of the
National Cancer Institute?
A. It has.
Q. In a journal called Cancer?
A. Yes, sir.
Q. Is Cancer one of the world's leading journals?
A. Yes, sir.
Q. Cell?
A. Yes.
Q. Chest?
A. Yes.
Q. Circulation?
A. Yes.
Q. Immunology?
A. Yes.
Q. The Journal of Cell Biology?
A. Yes.
Q. The New England Journal of Medicine?
A. Yes, sir.
Q. In all the --
Would you say that the vast majority of the leading
U.S. medical
journals have carried reports of research funded by the CTR Scientific
Advisory Board?
A. Yes, as documented here.
Q. How about international journals, have -- has
work funded by the CTR
SAB program appeared in international journals as well?
A. Numerous international journals.
Q. Is The Lancet --
What's the reputation for a journal called The Lancet
in the medical
community?
A. Lancet is one of the oldest medical journals.
It is a British
journal. Probably I would have to say if not the most respected, one
of the
most respected journals in the world.
Q. Has research funded by CRT's SAB appeared in
The Lancet?
A. Yes.
Q. In the British Journal of Cancer?
A. Yes.
Q. British Medical Journal?
A. Yes.
Q. How about leading French and European journals?
A. There also.
Q. Italian journals?
A. Yes.
Q. Israeli?
A. Yes.
Q. Scandanavia?
A. Yes.
Q. Germany and Japan?
A. Yes, sir.
Q. Has the United States Public Health Service ever
cited research
funded by the scientific Advisory Board in its Surgeon General reports?
A. Yes. I think cumulatively probably 300, 350 times.
Q. To your knowledge, has The Council for Tobacco
Research ever
suppressed the publication of research it funded?
A. No.
Q. Let's discuss now briefly some of the institutions
where CTR-funded
research has been conducted and some of the researchers, starting right
here. Could you turn to tab 14, Dr. Glenn.
A. I have it.
Q. That's demonstrative Exhibit 1925B, as in blue.
Can you identify
that document, Dr. Glenn? Is it a demonstrative chart relating to funding
in the state of Minnesota?
A. It is. These are CTR grantees in the state of
Minnesota.
Q. Dr. Glenn, before you go ahead, I need to move
it into evidence.
MR. WEBER: I'd like to move for demonstrative purposes,
Your Honor, the
admission of Exhibit 1925B.
MR. CIRESI: No objection, Your Honor.
THE COURT: Court will receive 1925B for demonstrative
purposes.
BY MR. WEBER:
Q. And can you describe just briefly what this is,
Dr. Glenn?
A. This is entitled "CTR Grantees in Minnesota."
Q. (Coughing) Excuse me.
And does it list those people who have received
grants from the
Scientific Advisory Board and conducted research in this state over
the
years?
A. It does.
Q. Has the CTR Scientific Advisory Board funded
research across the
United States as well, Dr. Glenn?
*9 A. Oh, it has, in virtually every state.
Q. Can you turn to tab 15. That's Exhibit 19 --
demonstrative Exhibit
1970.
A. Yes.
Q. Is that a chart demonstrative showing the geographical
spread of CTR
grant research?
A. It is.
MR. WEBER: Your Honor, I'd move the admission for
demonstrative
purposes of Exhibit 1970.
MR. CIRESI: No objection, Your Honor.
THE COURT: Court will receive 1970 for demonstrative
purposes.
BY MR. WEBER:
Q. Can we pull that up or not? Okay. Put the --
well, sorry I can't get
that to look any better.
Is this a chart that represents funding across the
country?
A. This is a map of the United States, and representative
grantee
institutions are listed here. This is not a complete list, but it does
show
the geographic distribution of grants that have been made over the
years.
Q. Has CTR funded research of major United States
universities?
A. Yes.
Q. Let me go through just a representative list
with you. And answer
"yes" or "no" on each one as to whether research has been funded there
through the SAB.
At Duke?
A. Yes.
Q. At Yale?
A. Yes.
Q. At Harvard?
A. Yes.
Q. MIT?
A. Yes.
Q. Stanford?
A. Yes.
Q. University of Chicago?
A. Yes.
Q. University of Minnesota?
A. Yes.
Q. University of Wisconsin?
A. Yes.
Q. Iowa University?
A. Yes.
Q. University of Michigan?
A. Yes.
Q. Johns Hopkins?
A. Yes, sir.
Q. Penn?
A. Yes.
Q. University of California?
A. Yes.
Q. Cornell?
A. Yes.
Q. Many others?
A. Yes.
Q. Has CTR also funded research at major biomedical
research
institutions in the United States and abroad?
A. It has.
Q. At the Dana Farber Institute?
A. Yes.
Q. Where is that located, doctor?
A. In Boston.
Q. And what is that?
A. It is a research institute that is affiliated
with the Harvard
Medical School and several of the Harvard hospitals.
Q. At the Mayo Clinic?
A. Yes.
Q. At the Fox Chase Cancer Center?
A. Yes.
Q. What is the Fox Chase Cancer Center?
A. Fox Chase is an independent cancer research institution
which has
affiliations with the Philadelphia Medical School.
Q. At the Scripps Institute?
A. Yes.
Q. Is that a major funder and performer or --
Is that a major research institution?
A. It is, and -- and a major clinical institution
as well, the Scripps
Clinic and Scripps Hospital.
Q. And has CTR funded research in overseas research
institutions?
A. Yes.
Q. Including the Karolinska Institute?
A. Yes.
Q. Where is that located?
A. In Stockholm, Sweden.
Q. Are you generally familiar with the reputations
of the institutions
and investigators and researchers who have been funded through the
SAB
grant program?
A. I am.
Q. And what is that reputation in the biomedical
community?
A. Well, I think, you know, these are the top institutions,
and the
investigators have been of first-rank quality, respected by their peers,
acknowledged by the biomedical research community to be outstanding
contributors.
*10 Q. You mentioned on Friday that one SAB member
had been nominated
for a Nobel Prize?
A. Well as a matter of fact three of them have.
Q. Members of the Scientific Advisory Board over
the years?
A. Yes.
Q. Have any of the CTR grantees ever been nominated
for the Nobel
Prize?
A. Yes, many of them, and three of them have --
have won the Nobel
Prize.
Q. Can you identify these grantees of CTR who have
won Nobel Prizes?
MR. CIRESI: Objection, Your Honor, it's irrelevant.
THE COURT: Oh, you may answer that.
THE WITNESS: Answer it, Your Honor?
THE COURT: Yes.
A. Dr. Baruch Benacerraf at Harvard won the Nobel
Prize. We supported
Dr. Benacerraf for a number of years. His work was in the area of molecular
biology. He's really considered to be a pioneer of molecular biology.
Second one was Dr. Stanley Cohen, whose work was
with growth factor.
Dr. Cohen is professor at Vanderbilt University Medical School in
Nashville. Dr. Cohen was the person who really opened up the field
of
growth factor. Growth factor is a substance that is virtually essential
for
cell proliferation, for cell growth.
And the third individual who won the Nobel Prize
for his work in
oncogenes, the cancer-causing gene, was Dr. Harold Varmus, who was
then
professor at the University of California-San Francisco, but who is
now the
director of the National Institutes of Health.
Q. And were these researchers awarded their Nobel
Prizes for research
in areas that included the areas that CTR had funded them in?
A. Yes, sir.
Q. Do CTR grantees typically get all of their research
funding from
CTR?
A. Oh, no. As a matter of fact, our funding many
times was in the form
of seed money, something to help get a project started. Our grants
were not
huge grants for the most part, 80, 85 thousand dollars a year, but
it would
get an investigator started on a given project. And usually those that
were
off to a successful start could then attract major funding from federal
funding sources.
Q. How does CTR know who -- what other institutions
may be funding a
researcher that they're funding?
A. Well in the grant application an investigator
is asked to list the
sources of funding that he has currently, as well as pending funding;
that
is, where he may have applied for additional funding, and of course
when we
receive the report from the investigator year by year, we know what
other
funding he's gotten because he tells us.
Q. And is it also disclosed in publications eventually?
A. Yes, as we discussed.
Q. And is it of any significance to those of you
affiliated with CTR
and the Scientific Advisory Board as to the fact that researchers funded
through the SAB program are also getting funding from other sources?
A. Well I think it's reassurance that our judgment
was correct in the
first place.
Q. Let me turn now to some changes in CTR over the
years, if I might,
Dr. Glenn.
During your tenure at CTR, has CTR engaged in any
active public
information, public affairs, public relations activities?
*11 A. No.
Q. Does CTR send out routine press releases any
more in your tenure?
A. Once a year we send a brief press release announcing
the publication
of the annual report, and it usually -- this little, brief blurb usually
says how much money we have expended for research grants during the
-- the
past year, the number of grantees that we've supported, and the cumulative
experience in supporting biomedical research, and that's about the
size of
it.
Q. And are the annual reports distributed to medical
schools and
medical libraries throughout the country?
A. Every medical school in North America, the deans
of all the medical
schools; also to all of our current and former grantees, we send a
copy of
the annual report so they can see for themselves the progress; these
reports are also sent to major newspapers along with the brief press
release.
Q. Based on your understanding of the history of
CTR -- and I know you
don't know everything, but based on what you do know -- do you know
whether
CTR in its earlier years played a more active or different role with
respect to public information and press activity?
A. Yes, they were more active.
Q. And did that activity diminish over time?
A. It did.
Q. Could you explain that for us in terms of your
understanding.
A. Well in the beginning, you know, under the terms
of the Frank
Statement, the TIRC, later the CTR, was charged with not only supporting
an
investigative program, but also with making public the information
that was
developed. By just -- within just a few years it was recognized that
the
public information charge was more appropriately done by another agency,
and The Tobacco Institute was formed, and it gradually took over the
function of public information.
Q. Do other research funders and other research
institutions have
public affairs or public relations offices?
MR. CIRESI: Objection, foundation, hearsay, irrelevant.
THE COURT: Sustained.
Q. Dr. Glenn, have the academic institutions and
hospitals that you've
been associated with over the years also had public relations or public
affairs offices?
MR. CIRESI: Objection, irrelevant.
THE COURT: Sustained.
Q. Dr. Glenn, what function, based on your knowledge,
do public affairs
or public information offices that are affiliated with universities
or
research institutions serve?
MR. CIRESI: Objection, irrelevant, foundation.
THE COURT: Sustained.
Q. Dr. Glenn, to your knowledge, did any public
relations activity at
CTR affect the quality of any research that was being done?
A. No, sir.
Q. Let me ask now about another change over the
years. Did CTR once
fund research through what was called CTR special projects?
A. Yes.
Q. When did CTR special projects begin, Dr. Glenn?
A. I believe in about 1965.
Q. Do you know when they ended?
A. About 1990.
Q. Was the CRT's scientific director involved at
all in approving CTR
special projects?
A. Yes. The scientific director reviewed every special
-- CTR special
project that was proposed by the sponsors, reviewing it primarily for
scientific merit, whether he thought it would add anything to the body
of
knowledge in the -- in the general field.
*12 Q. Did you approve any research of CRT's special
projects when you
were scientific director?
A. Not new projects, because the project -- the
special projects of CTR
were gradually winding down. I did approve a renewal of one of the
CTR
special projects.
Q. Do other funding institutions such as the National
Institutes of
Health use the term "special projects" to designate certain of their
research?
MR. CIRESI: Objection, Your Honor, it's irrelevant,
there's no
foundation.
THE COURT: Sustained.
MR. WEBER: Let me ask -- let me see if I can lay
some foundation here,
Your Honor.
MR. CIRESI: Your Honor, I'm going to object also
on irrelevance.
THE COURT: Okay. I don't know what that has got
to do with this case,
counsel. Why don't you move on.
MR. WEBER: Can I -- well can I try to ask one question,
see if I can
address this, Your Honor? I think it might address the court's concern.
THE COURT: Okay.
BY MR. WEBER:
Q. Does the term "special project" or "National
Institute of Health
special project" have a recognized meaning in the research community?
A. It does.
MR. CIRESI: Objection. Excuse me, doctor. It's irrelevant.
THE COURT: No, you may answer that.
Q. Dr. Glenn, would you like the question again
or do you remember it?
A. I remember the question.
Q. Okay.
A. The National Institutes of Health does have a
public relations
function and they do --
MR. CIRESI: Your Honor, --
MR. WEBER: No, --
MR. CIRESI: -- that's not --
MR. WEBER: -- that was not the question.
MR. CIRESI: Excuse me.
THE COURT: Okay. Do you want to try --
MR. CIRESI: He's given an answer to a different
question. I don't know
where that came from.
THE COURT: Okay. Do you want to try it again, counsel?
MR. WEBER: Yeah, I'll ask it again.
THE COURT: Okay.
BY MR. WEBER:
Q. Dr. Glenn, does the term "special project" or
"National Institute of
Health special project" have a recognized meaning in the medical research
community?
A. Yes.
Q. What does that mean to those of you in the medical
research
community?
MR. CIRESI: Again, Your Honor, I'm going to object
on relevance
grounds.
THE COURT: No, you may answer that.
A. Special projects are projects supported by the
NIH or another agency
with a specific purpose. It's more in the line of contract research
than it
is the usual competitive grant-in-aid.
Q. Were CTR special projects handled separately
from the SAB grant
program?
A. Yes.
Q. Were CTR special projects reported in the annual
report?
A. No.
Q. Did funds for CTR special projects come out of
the or take away from
the Scientific Advisory Board's research budget?
A. No. They were independently funded.
Q. How did the amount spent on CTR special projects
over the years
compare to that spent on -- the money spent in the grant program?
MR. CIRESI: Objection, Your Honor, it's already
been testified to. We
put a document in on his cross-examination with regard to it.
*13 THE COURT: Okay. I think we covered it once.
I'll -- I hope we
aren't going to go into depth again; are we?
MR. WEBER: No, we're not.
THE COURT: Okay. Go ahead.
Q. Go ahead, do you remember --
A. I don't remember the exact figures, but it amounts
to only a
fraction of the total SAB grant funds.
Q. Did you understand that CTR special projects
were suggested by the
sponsors of CTR?
A. Yes.
Q. Do you know whether lawyers may have suggested
some of those
projects to the sponsors?
MR. CIRESI: Objection, Your Honor, he testified
last Friday he didn't
know.
THE COURT: Okay.
MR. WEBER: Well may I respond?
THE COURT: You're going to respond to counsel?
MR. WEBER: Yes.
THE COURT: I thought we were going to have a question
and answer
between the attorney and the witness. Okay.
MR. WEBER: Yes, I'm sorry.
THE COURT: If you have a question, ask the witness.
MR. WEBER: I'm sorry, I didn't hear the ruling on
that, Your Honor.
THE COURT: Okay. The ruling is overruled.
MR. WEBER: Excuse me. I'm still a little stuffed
up, so I -- excuse me.
BY MR. WEBER:
Q. Do you remember the question, Dr. Glenn?
A. No.
Q. Okay. Did you have an understanding as to whether
lawyers may have
been people who suggested to the sponsors that certain special projects
be
done?
A. I didn't understand that, but it's not unreasonable
that they would
have been consulted.
Q. Does the fact that the sponsors or perhaps even
their lawyers may
have suggested that certain research be funded make that research itself
unreliable?
MR. CIRESI: Objection, it's speculation, there's
no foundation for this
witness.
THE COURT: Well what you're -- you are getting very
leading, counsel. I
wonder if you could --
MR. WEBER: Okay.
THE COURT: -- make your questions a little more
general.
BY MR. WEBER:
Q. Does -- how do scientists -- strike that. Does
the --
Does who sponsored the research control the question
of whether
research is reliable or not?
A. No.
MR. CIRESI: Excuse me, doctor. Your Honor, I'm going
to object to that.
Whose research? In what year? There's no foundation, it's vague and
overbroad.
THE COURT: I expect you will ask him something more
specific. I'll
allow the question and you may answer it.
A. No, sir.
Q. Go ahead.
A. The source of funding does not dictate the quality
or the type of
research.
Q. In your 46 years in academic medicine and being
involved in research
and being on funding organizations, do you have an understanding as
to how
scientists judge the quality of published research?
A. Yes.
Q. How is that done?
A. Well the presentation of scientific research
may be in the form of a
verbal presentation, oral presentation at a medical meeting. Papers
to be
presented at a medical meeting are reviewed by a committee of peers,
of
people who are knowledgeable in that area. And it's competitive. They
are
not going to accept -- at a qualified medical meeting they will not
accept
presentation of shoddy or inaccurate research.
*14 The same thing holds true for publication. The
articles submitted
for publication in these hundreds of medical journals are reviewed
by an
editorial board of peers, people who are knowledgeable in the field,
and
those papers that are -- are not of quality are rejected.
Q. Dr. Glenn, have you come --
Do you have an understanding as to why CTR special
projects were funded
through CTR?
A. Yes.
Q. Could you explain that.
A. I think it was purely a matter of convenience.
The funding mechanism
in medical research institutions, medical schools, clinics, hospitals,
is
different from the usual course of business. Each institution will
have a
grants and contracts office, and they will have a financial officer
that is
in charge and is responsible for receiving the funds.
CTR staff were accustomed to dealing with institutions
and providing
the funds and receiving reports of expenditure of funds, so it was
a
convenience for the sponsor companies simply to fund these special
projects
of CTR through the CTR offices.
Q. Has CTR compiled a list from its records of CRT's
special projects?
A. Yes.
Q. Could you turn to tab 16, Dr. Glenn, and that
would be Exhibit
AM005003.
A. Yes, I have it.
Q. Can you identify that as a list from CRT's records
of CRT's special
projects?
A. Yes.
MR. WEBER: Your Honor, I'd move the admission of
Exhibit AM005003, a
list of special projects of CTR.
MR. CIRESI: I have no objection to this, Your Honor.
THE COURT: Court will receive AM005003.
MR. WEBER: (Coughing) Excuse me.
BY MR. WEBER:
Q. Approximately how many CTR special projects were
there, Dr. Glenn?
A. Approximately 110.
Q. Were all CTR special projects original laboratory
or scientific
research?
A. Not in the early days. I think there were some
focus studies that
were epidemiological surveys, literature reviews, but toward the end
of the
special projects they were original research, yes.
Q. Did CTR have a policy regarding the publication
of research results
resulting from original research in CRT's special projects?
A. Yes.
Q. What was that policy?
A. The same policy that we had for grants and contracts,
and that was
that publication was the responsibility of the investigator, and they
were
encouraged to -- to present or publish their work in the standard
scientific manner.
Q. Dr. Glenn, could you turn to tab 17.
MR. WEBER: And Your Honor, may I approach? It's
another composite
exhibit list.
Do we have a copy for Mr. Ciresi?
BY MR. WEBER:
Q. Dr. Glenn, does tab 17 collect funding letters
to researchers
receiving CTR special projects?
A. Yes, sir.
Q. And is that a complete collection of the letters
that exist in
informing a researcher of their approval as a special project for CTR
as
from the files of CTR?
A. Yes, it does.
MR. WEBER: Your Honor, I'd move the admission through
Exhibit 50003,
which lists numbers, of the exhibits listed thereon.
MR. CIRESI: Once again, Your Honor, we have no objection
in order to
expedite matters, so long as we have an opportunity to verify.
*15 THE COURT: All right. Court will receive Exhibit
50003.
BY MR. WEBER:
Q. Now Dr. Glenn, could you turn within tab 17 to
the exhibit listed
MD001076.
A. It's going to take me a long time to find that,
counselor.
Q. Well why don't we do it this way then. Why don't
you --
Oh, these are the numbers on the left-hand side,
Dr. Glenn. That might
make it easier.
A. Oh, I'm sorry.
MR. WEBER: May I approach, Your Honor, to speed
this up?
Q. See the exhibit numbers down here, Dr. Glenn?
Wait, you're almost
there. MD001076. Do you see that?
A. Correct.
Q. And I will ask you a couple more of these, and
that's where you'll
find those numbers.
Can we bring that up?
Now is this a letter sent to a researcher who was
going to receive CTR
special project funding?
A. Yes.
Q. And can you describe or read that letter and
explain its purpose at
CTR.
A. Well it's to Dr. Doris Herman in the Department
of Pathology,
University of Southern California in Los Angeles, refers to a letter
of May
25th confirming the financial assistance which she had requested. It's
written by Dr. Hoyt, who said he inadvertently failed to mention that
our
records will designate your undertaking as a special project of The
Council
for Tobacco Research rather than a grant-in-aid, and it further tells
her
that if a credit line should be inserted into any future publication,
it
should be so worded in order to avoid its being confused with the grant
program of the Scientific Advisory Board.
Q. Now Dr. Glenn, could you continue on to MD001108,
which is another
letter. And maybe to make it quicker, Dr. Glenn --
A. I have it.
Q. Okay. And that's a letter to Dr. Macdonald?
A. No, sir, --
Q. Okay.
A. -- I don't have it.
Q. Why don't you look on the one on the screen then.
Is that 1108?
A. Yes.
Q. All right. That's a letter to Dr. Eleanor Macdonald?
A. Yes.
Q. Okay. And again in that second-to-the-last paragraph,
could you read
that?
A. "Our records will designate this undertaking
as a special project of
The Council for Tobacco Research-U.S.A., Inc., rather than a grant-in-aid.
If a credit line should be inserted into any future publications, it
should
be worded to avoid its being confused with the grant program of the
Scientific Advisory Board."
Q. All right. And are these examples we've seen
consistent with the
types of letters that were sent to special project recipients?
A. Yes. I -- I have reviewed many of these letters,
and they all
contain similar wording.
Q. Generally they all contain that wording.
A. Yes.
Q. Now did CTR special project researchers in fact
publish their work?
A. Yes.
Q. Are the publications of CTR special projects,
research of which CTR
is aware, listed in Exhibit AM005003, which is at tab 16, and that's
the
list of special projects that were admitted into evidence just a little
earlier?
A. Yes.
Q. And you've reviewed that list; haven't you, doctor?
*16 A. Yes, sir.
Q. Were the results of CTR special project research
generally published
in quality scientific peer-review journals?
A. Generally, yes.
Q. Did research funded of CTR special project research
include research
undertaken at quality institutions?
A. Yes, sir.
Q. Can you turn to tab 18, which is Exhibit 1217.
A. I have it.
Q. And is that a representative -- demonstrative
chart representing
some of the institutions that received special project research?
A. Yes, sir.
MR. WEBER: Your Honor, I'd move the admission of
Exhibit 1217 for
demonstrative purposes.
MR. CIRESI: No objection, Your Honor.
THE COURT: Court will receive 1217 for demonstrative
purposes.
BY MR. WEBER:
Q. Now are these some of the institutions that have
received CTR
special project funding, Dr. Glenn?
A. Some, but not all. This is not an inclusive list.
Q. And are these quality research institutions?
A. Absolutely.
Q. Did other quality funding organizations also
support research and
researchers who were at the same time being supported by CTR special
project funding?
A. Yes.
Q. Could you turn to tab 19, which is demonstrative
Exhibit 1218.
A. I have it.
Q. Is that a listing of some other organizations
that also funded CTR
special project research?
A. It is.
MR. WEBER: Your Honor, I'd move the admission of
Exhibit 1218 for
demonstrative purposes.
MR. CIRESI: No objection, Your Honor.
THE COURT: Court will receive 1218 for demonstrative
purposes.
BY MR. WEBER:
Q. Now how is it that CTR developed this representative
list of other
organizations that were funding CTR -- were funding research that was
also
being funded as a CTR special project?
A. Well again, this would come from the footnote
credit line of the
papers published by the investigators where they would acknowledge
support
by CTR as a special project, along with support from one or more of
these
additional institutions and other agencies as well.
MR. WEBER: Your Honor, I'm going to take a slight
change in topic here,
and I can take a break whenever the court would want. I just --
THE COURT: All right. Well let's take a short recess
now.
MR. WEBER: Okay.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
MR. WEBER: Thank you, Your Honor.
BY MR. WEBER:
Q. Dr. Glenn, last week Mr. Ciresi asked you some
questions about
several specific research projects, and I want -- I want to follow
up on
some of that inquiry.
Do you recall questions about a 1971 proposal to
fund the research at
Washington University --
A. Yes, sir.
Q. -- regarding immunological issues and cancer?
A. Yes.
Q. Was that ever funded as a CTR special project?
A. Not according to my record review.
Q. Was it ever funded as a CTR grant?
A. Not to my knowledge, no.
Q. Do you know if it was ever funded in some other
manner by the
companies?
*17 A. No.
Q. You have no knowledge one way or the other.
A. I do not.
Q. Mr. Ciresi also asked you some question about
grants to researchers
who were named Spielberger and Aviado. Do you remember that?
A. Yes.
Q. And he questioned whether CTR might have suppressed
that research.
Do you remember that question?
A. Yes.
Q. Did CTR fund a researcher named Spielberger with
a CTR special
project?
A. Not according to our records.
Q. Did CTR fund a researcher named Spielberger with
a grant?
A. No.
Q. You have no knowledge whatsoever about any research
performed by
Spielberger.
A. No.
Q. Did CTR fund Dr. Aviado with a CTR special project?
A. I believe so.
Q. Do you know if that is the project referred to
in the document that
Mr. Ciresi showed you?
MR. CIRESI: Objection, Your Honor, foundation.
THE COURT: Okay. Well you may answer that.
A. Dr. Aviado also was a grantee. I'm not sure which
is referred to.
Q. Or whether it's some other project.
MR. CIRESI: Well, Your Honor, I'm going to object
to counsel's leading
question. There's no foundation.
THE COURT: Yeah, that was leading, counsel. Sustained.
Q. Do you know --
Do you know what specific project was referred to
in the document Mr.
Ciresi showed you?
MR. CIRESI: Objection, no foundation. The witness
has just testified.
THE COURT: I believe he's answered that, counsel.
BY MR. WEBER:
Q. With respect to the CTR special project funding
for Dr. Aviado,
could you turn to page -- to tab 23. And these are exhibits that are
already in evidence, MD001143, MD001150. Those are part of the special
project letters that were admitted earlier.
A. I have them.
Q. And let me show you first Exhibit 001143. Do
you have that one?
A. I do.
Q. January 1978?
A. Yes, sir.
Q. And does that talk about Dr. Aviado's right to
publish in the
future, down in the second-to-the-last paragraph?
A. Yes.
Q. And is this a typical letter to a CTR special
project recipient?
A. Yes, it is, similar to the previous letters that
we reviewed.
Q. And could you turn to Exhibit 1150, which I believe
should be next
in your tab. Do you see that?
A. I have it.
Q. That relates to the same special project number
93?
A. Yes, sir.
Q. Does that also refer to potential future publication?
A. Yes.
Q. Do you have any information that CTR ever did
anything to advise Dr.
Aviado not to publish?
A. No.
Q. Did CTR ever fund projects through device or
an account called
special account four?
A. I don't know what special account four is.
Q. Does CTR have any files that include -- that
are labeled special
account four?
A. No.
Q. Did CTR ever fund research through anything called
lawyers' special
projects?
A. No.
Q. Does CTR have a file for lawyers' special projects?
A. No, sir.
Q. To the best of your knowledge, doctor, and taking
into account your
46 years in academic medicine and your work in the research community,
do
you believe that it was unethical or improper for CTR to fund research
as
CTR special projects?
*18 MR. CIRESI: Objection to the form, no foundation,
calls for an
expert opinion, and also calls for an ultimate conclusion of fact by
the
jury.
THE COURT: Sustained.
BY MR. WEBER:
Q. Based on your knowledge from your review of materials,
do you
believe that CTR did anything improper or unethical with respect to
funding
CTR special projects?
MR. CIRESI: Same objections, Your Honor.
THE COURT: Sustained.
Q. Dr. Glenn, would you turn to Exhibit 11028. It's
at tab 24. It's an
exhibit already in evidence.
A. I see that.
MR. CIRESI: Do you have a exhibit number, counsel?
MR. WEBER: 11028.
Q. Is that one of the documents that Mr. Ciresi
showed you last week?
A. Yes, sir.
Q. I'd like you to turn to the front page of that.
Do you know any of
these individuals, Bentley, Felton or Reid?
A. No.
Q. Do you know what their scientific capabilities
were?
A. No.
Q. Is this a document that was in CRT's files?
A. No.
Q. Had you ever seen this document as part of your
duties at CTR, apart
from litigation?
A. No, sir.
Q. Turn to the first page, which is the itinerary.
You remember Mr.
Ciresi asking you some questions about that?
A. Yes.
Q. Is --
At the time was R. J. Reynolds a sponsor; that is,
in 1958 was R. J.
Reynolds a sponsor of TIRC?
A. Yes, they were.
Q. Was R. J. Reynolds visited on this trip?
A. No, sir, not according to this itinerary.
Q. According to this itinerary was Lorillard visited
on this trip?
A. No, sir.
Q. According to this itinerary was Brown & Williamson
visited on this
trip?
A. Not according to this itinerary.
Q. Could you take a look through that document and
let me know whether
it purports to quote directly anyone from the CTR?
A. I've reviewed this document previously, and I
found no direct quotes
from anyone at CTR.
Q. Are you able to vouch for the accuracy of any
of the
characterizations of conversations in there, sir?
A. No.
MR. CIRESI: Excuse me, doctor. That calls for speculation.
He's already
said he's never saw it before.
THE COURT: No, he can answer the question. It's
been answered.
MR. WEBER: He can? He can answer?
THE COURT: He's already answered.
MR. WEBER: Okay. I'm sorry, Your Honor.
BY MR. WEBER:
Q. Let me ask you this, Dr. Glenn: Could you read
that bottom paragraph
on the page marked 492 from this document.
A. "The SAB," Scientific Advisory Board, "of TIRC
and the group we at
the National Cancer Institute, Bethesda, broadly take the view that
causation is likely to be indirect. Several hypothetical means by which
this could occur were proposed but with no experimental evidence to
support
any of them."
Q. All right. And I'd like to go to the next page,
493, and ask if you
could read that first paragraph under "EXTRAPOLATION FROM ANIMAL TESTS
TO
MAN."
A. "Without exception no single individual whom
we met was prepared to
extrapolate unambiguously from any single animal test to man. At the
same
time there was general agreement that in the field of smoking and lung
cancer no biological test wholly free from criticism is available at
the
present time or is likely to become available in the foreseeable future."
*19 Q. Now does that express an opinion that you
agree with, Dr. Glenn?
A. Yes. I would certainly have agreed at that time,
40 years ago, and I
-- I think we still have the ambiguities.
Q. Could you go to the page labeled 496.
A. I have that.
Q. And start at the paragraph that begins at the
bottom of the page and
goes over to the next page. Could you read that paragraph.
A. "Others, including the Scientific Advisory Board
of TIRC and a group
at the National Cancer Institute, do not accept that a case has yet
been
made that tobacco smoke is directly carcinogenic to the human lung.
While
accepting broadly that cigarette smoking may be said to be capable
of,
quote, causing, unquote, lung cancer they argue that the evidence favors
some indirect mechanism of causation. If this is so, of course, cancers
produced by skin painting, and even more so, cell changes produced
by
short-term screening tests are misleading artifacts. Unfortunately
so long
as the basic problems underlying the transformation of a normal to
a
cancerous cell remain unsolved, theories of indirect causation must
be
largely speculative and almost without exception incapable of being
tested
experimentally. The advice we had from this group, which includes Dr.
Little, was that T.M.S.C. should concern itself less with direct testing
of
cigarette smoke on animals than with fundamental work on carcinogenesis.
An
idea which we frequently encountered was that of an institute financed
say
by T.M.S.C. which would support a number of dedicated individuals of
proved
caliber who would devote their time to long range basic research on
cancer
without being distracted by administrative duties or financial worries.
No
short or medium-term solution to the problems facing the industry could
be
expected from such an institution, which would necessarily have to
have no
strings attached, but very long-term beneficial results might be expected."
Q. Could you turn back to page 492, Dr. Glenn, and
in the paragraph
labeled "'CAUSATION' OF LUNG CANCER" -- do you see that?
A. Yes, sir.
Q. Could you begin reading where it talks about
Hueper of the National
Cancer Institute. Do you see that?
A. Yes, sir.
Q. Could you read that.
A. "Hueper of the National Cancer Institute accepts
that cigarette
smoke is capable of causing lung cancer but believes that as compared
with
other environmental carcinogens the contribution of smoking to the
total
mortality from lung cancer is being greatly exaggerated."
Q. Now doctor, turn to page 498, please.
A. Yes.
Q. Do you see the second conclusion down there --
A. Yes.
Q. -- at the bottom of the page? That hasn't been
read to the jury yet.
Could you read conclusion two.
A. Conclusion two states: "There remains an area
of debate to what is
meant by, quote, causation, end quote. Opinion differs as to whether
or not
cigarette smoke is likely to exert its effect by direct action on the
lung.
An indirect mechanism of causation is thought by some to be more likely."
*20 Q. Now, sir, this was in a 1958 document?
A. Yes.
Q. And again, you don't know the authors or the
accuracy of the report;
correct?
A. No.
Q. Did you take a look to see what the Scientific
Advisory Board itself
said in this same period about the issue of causation?
A. I think they were saying the same things, that
there were real
questions as to whether there was a direct effect on the lung of cigarette
smoking.
Q. Did you look at the minutes of the Scientific
Advisory Board --
A. I did.
Q. -- to -- to determine what the Scientific Advisory
Board itself said
about this issue of causation?
A. Yes.
Q. Could you turn to the Scientific Advisory Board
minutes, which is
Exhibit MD001258, I believe. Those should be in a separate binder up
there.
They were admitted into evidence already.
A. Tell me the number again, please, sir.
Q. It's Exhibit MD001258. Those are the minutes
of the Scientific
Advisory Board.
A. Yes.
Q. May I approach --
A. I have those.
Q. Okay. And could you turn to the page that is
Bates stamped at the
bottom 153.
A. What would be the date on that?
Q. It would be March 10, 1960, and the page -- the
stamp at the bottom
of the page would be 153, Dr. Glenn.
A. I go from 152 to 154. I can read the --
Q. Do we have a copy of that?
Well let me ask you to identify this as page 153,
on the screen.
A. Yes.
Q. And is this the cover sheet to a meeting of the
Scientific Advisory
Board in March 10 and 11 of 1960?
A. It is.
Q. Do you have page 157 there, Dr. Glenn?
A. Yes.
Q. And is 157 a report by the Scientific Advisory
Board to the TIRC?
A. Yes.
Q. And that was part of the minutes of that meeting?
A. Yes.
Q. I'd like you to turn to the next page, 158. Do
you have that, sir?
A. I do.
Q. And ask you to turn to the paragraph that begins
"Even though...."
A. Yes.
Q. And to read that portion of the report of the
Scientific Advisory
Board in 1960.
A. "Even though it must be admitted that the effort
thus far has barely
scratched the surface, excellent scientific studies have been reported,
and
it can confidently be assumed that the facts revealed will ultimately
contribute to the solution of the broad questions which concern us.
But
perhaps the most significant development has been the general recognition
that we do not yet have the answer; that an association between the
extent
of tobacco use and the incidence of lung cancer does not prove a causal
relationship, that experimental verification is essential and that
there
are a number of other factors which need to be considered. Today, instead
of letting the problem rest with the statement that to smoke in excess
of
two packs of cigarettes per day results in a ten-fold increase in the
risk
of cancer, there is general interest in the 90 percent of heavy smokers
who
escape the disease despite heavy smoking. We are also vitally interested
in
the meaning of the results, derived from the same data, that only a
small
fraction of the reported excess deaths in the heavy smoking group is
attributable to cancer of the lungs."
*21 Q. Dr. Glenn, from your standpoint, if one wanted
to find out the
view of the Scientific Advisory Board on the question of causation,
is it a
more reliable source to look to the Scientific Advisory Board's own
report,
or to look to a report from some British people?
MR. CIRESI: Object to the form of the question,
Your Honor.
THE COURT: Sustained.
Q. This is the SAB's own words in 1960; correct?
A. Yes, sir.
Q. Could you turn to Exhibit 11027, Dr. Glenn, which
is at tab 25.
A. I have that.
Q. And is this a --
Is Exhibit 11027 one of the plaintiffs' exhibits
that Mr. Ciresi showed
you the other day?
A. Yes, it is.
Q. Had you ever seen this, apart from litigation?
A. Only in connection with litigation.
Q. Is this document in CRT's files?
A. No, sir.
Q. Who's the author of this document, can you tell?
A. I can't tell. I -- it's --
Having looked at it previously, I couldn't tell
who wrote it.
Q. Is there a signature or a name listed on it anywhere?
A. No, sir.
Q. Are there any direct quotes here from the CTR?
A. No, sir.
Q. Could you turn to the page -- and I'll just give
you the last three
numbers of the Bates stamp in the lower right corner, Dr. Glenn, because
the pages aren't otherwise numbered -- page 269.
A. Yes, sir.
Q. And I'd like to direct your attention to the
first full paragraph at
the top of the page.
A. Yes, sir.
Q. And this is referring to --
This purports to be a report on a conversation with
Dr. Wakeham.
A. Yes.
Q. Can you read what that says?
A. "Wakeham said that polycyclics were effective
in contributing to
cancer in mouse skin painting, but the quantities in smoke were too
small
to be significant, as the Surgeon General Advisory Committee report
had
stated."
Q. Now that says "SGAC," but that refers to Surgeon
General's Advisory
Committee; correct?
A. Yes.
Q. And is that the point you made last Friday in
your testimony?
A. Yes.
Q. Could you turn to the page labeled 290, Dr. Glenn.
A. Yes, I have that.
Q. And does this purport to be a report of a meeting
with Dr. M. H.
Seevers?
A. It is labeled "Discussion with Dr. M. H. Seevers,
Ann Arbor,
Michigan, October 1, 1964."
Q. Did Dr. Seevers have any involvement with the
Surgeon General's
Advisory Committee in 1964?
A. Dr. Seevers was the chairman of the Surgeon General's
Advisory
Committee.
Q. He was a member of that committee; correct?
A. Yes.
Q. Let me just show from the 1964 report a list
of the members here.
That lists Dr. Seevers at the bottom; correct?
A. Correct.
Q. Now this document in front of you purports to
reflect a discussion
with Dr. Seevers in October '64?
A. Yes, sir.
Q. And that's about 10 months after the issuance
of the Surgeon
General's report?
A. Yes.
Q. I'd like you to start reading about AMA research
into smoking and
health there, and I'll have a few questions as we go along, Dr. Glenn.
*22 A. "To date, the committee (of which Seevers
is chairman) appointed
by the Education and Research Foundation of the AMA to direct the programs
for using the 10-million-dollar fund contributed by the U.S. cigarette
manufacturers, has approved 28 grants. The total cost of these over
the
periods for which they have been approved will be $2,400,000. Details
of
the grants are attached."
Q. Okay.
A. "The main considerations" --
Q. Continue, please.
A. "The main considerations which have been in the
minds of the Seevers
committee in making these grants have been:
"(1) It is necessary to get more good people to
undertake research in
the smoking and health field, whether or not they live in the U.S.
"(2) Research into cancer is not excluded but it
has been
over-supported in relation to other aspects. Under-supported have been
research into respiratory disease, cardiovascular disease, cellular
studies, ciliary activity, pharmacological and psycological reasons
for
smoking.
"(3) It is particularly necessary to find means
of determining nicotine
in the blood and organizing a supply of radio-active nicotine. The
Committee aim particularly at developing techniques.
"(4) The Committee do not plan to build their own
laboratory though
they may use the general medical research laboratory being built for
the
ERF of AMA in Chicago.
"Where gaps exist, the Committee will initiate research
projects to
close them. They already have two or three such projects.
"(6) The Committee is not concerned with modifications
to cigarettes,
how to treat tobacco et cetera. The manufacturers are more competent
to do
this. Similarly, the Committee is not concerned with cigarette tars,
which
would require a laboratory for their production.
"(7) The House of Delegates of the AMA, in accepting
the fund, looked
to it being used for the development of safe cigarettes. The Committee
considered that they were not set up to do this, and had no manufacturing
competence, et cetera - Seevers said they had a hard time getting away
from
this objective.
"(8) The Committee would support epidemiological
studies if they
received good applications.
"(9) The Committee may support research in more
fields as they get more
and more projects going.
"(10) They may add other experts (an example, pathologists)
to the
Committee; just feeling their way at present.
"(11) If they find good projects, they won't hesitate
to spend over the
10 million dollars as the AMA would have no difficulty in finding more
money.
"(12) They have refused to finance anti-smoking
clinics or education.
"(13) They expect to co-operate closely with CTR."
Q. Let me stop you there for a moment, Dr. Glenn.
This refers to a 10-
million-dollar grant given by the cigarette manufacturers to the AMA?
A. Yes, sir.
Q. And the AMA set up a board of scientific advisors
to approve
research applications?
A. Yes.
Q. Were you one of the researchers back in those
days who received a
grant from the AMA pursuant to this?
*23 A. My laboratory -- my laboratory, the laboratory
under my
direction, received a grant for study under the American Medical
Association Education and Research Fund.
Q. Would you go to the next page, Dr. Glenn, where
it reports -- the
page that begins "Seevers' personal views...."
A. Yes, sir.
Q. Now again, Dr. Seevers had been on the Surgeon
General's committee
that had issued the report 10 months earlier; correct?
A. Correct.
Q. What does this say about Dr. Seevers' personal
views?
A. "1. Seevers does not believe that it has been
proved that smoking
causes lung cancer. There is an association and it should be made known.
The strongest evidence for a causal connection is Auerbach's work,
but it
is not conclusive. Seevers is not sure the validity of the statistics."
Q. The next --
Could you read the next paragraph as well.
A. "2. Seevers is convinced the main reason why
people smoke is the
nicotine. He thinks it important to keep the nicotine content up. He
has
suggested to Hanmer of The American Tobacco Company that they should
add
back nicotine to cut the tobacco and then reduce both nicotine and
tar, as
in Carlton, by filter and porous paper. To produce a non-tobacco cigarette
was contrary to common sense."
Q. Could you go now, Dr. Glenn, to the page 294.
A. Yes, sir.
Q. And this continues the purported characterization
of the discussions
with Dr. Seevers; correct?
A. Yes.
Q. What does this say about the Surgeon General's
Advisory Committee?
A. "Seevers said that it was a committee of prima
donnas. Although none
of the members had published expressed views on smoking and health
they all
had very definite views. The Surgeon General never came near the committee.
Handley acted as chairman of the meetings; he was pleasant but ineffective,
allowing far too much irrelevant chat. Bains-Jones, as oldest member,
had
to step in from time to time to get points settled. Two whole days
were
spent discussing the meaning of, quote, cause, unquote. The political
people tried to hurry up the committee but did not otherwise try to
influence them. The, quote, member responsible for cancer (probably
Furth)
submitted a draft for the chapter on cancer that had been written by
the
American Cancer Society. This was thrown out."
Q. Now, do you remember the earlier trip report
that we discussed, I
think that was Exhibit 11028 from 1958, and it talked about how there
was a
debate as to what the meaning of "cause" was. Do you remember that?
A. Yes.
Q. And here we see that Dr. Seevers in October 1964,
according to this
document, did not believe that it had been proven that smoking caused
cancer; correct?
A. Yes.
Q. And Dr. Seevers, again according to this document,
says that two
whole days were spent by the Surgeon General's committee discussing
the
meaning of "cause." Do you see that?
A. Yes.
Q. I'd like to turn you now to the 1964 Surgeon
General's report, Dr.
Glenn. What tab is that? I think it's tab 43, MD000102. That's already
in
evidence.
*24 A. I have that.
Q. And could you turn to page 21 then.
A. I have that.
Q. And could you turn to paragraph four, paragraph
number four in the
causality section.
A. Yes.
Q. And this is where, in the introduction, they're
discussing
causality; correct?
A. Yes.
Q. All right. Can you read that to the jury.
A. "It should be said at once, however, that no
member of this
committee used the word 'cause' in an absolute sense in the area of
this
study. Although various disciplines and fields of scientific knowledge
were
represented among the membership, all members shared a common conception
of
the multiple etiology of biological processes."
Q. Let me stop you there. What does "multiple etiology"
mean, Dr.
Glenn?
A. Means that there may be many, many factors involved
in the genesis
of any particular condition, whether it be cancer or other disease.
Q. You mean "etiology" means cause?
A. Means causes.
Q. So this means --
This says everyone agreed that there were many causes.
A. Yes.
Q. Would you continue.
A. "No member was so naive as to insist upon mono-etiology
in
pathologic processes or in vital phenomena. All were thoroughly aware
of
the fact that there are series of events in occurrences and developments
in
these fields, and that the end results are the net effect of many actions
and counteractions."
Q. Now, Dr. Glenn, does the fact that "cause" was
not used in an
absolute sense, the fact that there was a common conception of multiple
etiology, and that no one was so naive as to insist upon mono-etiology,
would you explain how those ideas relate to your statements the other
day
about the importance of defining "cause?"
MR. CIRESI: Objection to the form of the question,
Your Honor. It's a
multiple question. It's also impeaching his own witness.
MR. WEBER: I object and move to strike that comment,
Your Honor. It's
entirely inappropriate.
MR. CIRESI: It's an inappropriate objection, impeaching
their own
witness.
THE COURT: Okay. You'll have to rephrase your question,
counsel.
BY MR. WEBER:
Q. Dr. Glenn, taking into account Exhibit 1127 that
talked about a
definition of "cause "-- you remember that?
A. Yes, sir.
Q. -- and 1128, where we saw Dr. Seevers' personal
views as reported in
that document -- correct?
A. Yes, sir.
Q. -- and taking into account this paragraph four,
do those documents
along with your learning relate in any way to the need to agree upon
a
definition of "cause" when discussing chronic disease?
A. Yes.
Q. Could you explain that.
A. Well I -- I don't know that there's any simple
explanation. We have
said that in order to establish cause, it should be -- it should have
some
universality, that we ought be able to reproduce results. Here in this
document and in the others that we've looked at it is clear that scientists
even 30, 40 years ago were worrying about the same questions. This
has led
to the -- to the recognition that there are multiple risk factors involved
in a number of diseases. And to digress from lung cancer, you can take,
for
example, arteriosclerosis. We know that diet plays a role, the level
of
your cholesterol, we know that activity plays a role, we know that
hormones
play a role, so there are multiple causes of arteriosclerosis. The
same
thing can be said of virtually every disease, that there are a number
of
factors that are involved. We probably have only just seen the tip
of the
iceberg, but at least we've come to the recognition that there are
fundamental problems.
*25 And the thing that the scientific community
has done most
effectively, I think, is to -- is to recognize that there are marked
individual differences which may underlie everything. These individual
differences are genetics. Probably the best thing we can do to avoid
disease is to pick the right parents, because our -- our -- our
inheritance, our genetic makeup --
MR. CIRESI: Your Honor, we're going beyond the scope
of this witness's
examination.
Q. All right, Dr. Glenn, let me move to a different
topic now.
Has CTR, to your knowledge, been represented by
counsel since its
inception?
A. Yes.
Q. Why does a research organization, in your mind,
need to be
represented by counsel?
MR. CIRESI: Objection, Your Honor, it's vague and
overbroad.
THE COURT: I'm not sure that it's relevant, counsel.
MR. WEBER: The relevance is, if you'll give me a
few questions, I'll
make -- make it clear because I'm leading up to a specific situation,
Your
Honor.
THE COURT: Okay.
BY MR. WEBER:
Q. Can you explain why a research organization,
based on your
experience, needs to be represented by counsel?
A. I think there are a variety of reasons. Any research
organization,
any university I've ever been associated with, any hospital, has counsel,
because you enter into contracts for research, you -- you subscribe
to
certain conditions of a grant, you have fiscal responsibility,
responsibility for the money that's involved. There are always antitrust
issues, for example, in an organization such as the CTR.
MR. CIRESI: Excuse me, Your Honor. We're now well
beyond what this
gentleman is here for.
THE COURT: We aren't going to get into his version
of antitrust issues.
MR. WEBER: Not his version of law, but in specific
situations I want to
get into, Your Honor.
Q. Based on your experience at CTR and the fact
that it's sponsored by
companies, independent companies in the marketplace, has CTR received
advice on antitrust issues from time to time?
A. Yes.
Q. Now without revealing any of the substance of
that advice, are you
aware of a situation back in the 1970s when the Scientific Advisory
Board
received advice on antitrust issues?
MR. CIRESI: Your Honor, if he's going to testify
to this, it opens up
the subject, and we will be entitled to the documentation regarding
it,
which has been resisted.
THE COURT: Counsel, I suggest you use extreme care.
MR. WEBER: May I be heard at side bar on this, Your
Honor.
THE COURT: Yes, you may.
(Side-bar conference)
BY MR. WEBER:
Q. Let's talk for a minute, Dr. Glenn, about the
scope of the SAB
research program and its relevance to the purpose of The Council for
Tobacco Research. All right?
First of all let me ask you: Have the companies
ever told you that
CRT's Scientific Advisory Board should avoid certain areas of research?
A. No, sir.
Q. Now do you recall Mr. Ciresi asked some questions
last week about
criticisms of CTR by scientists in the various sponsor companies in
the
sixties and seventies?
*26 A. Yes.
Q. Do you recall that some of those documents suggested
that CTR should
be redirected or restructured?
A. Yes.
Q. That company scientists should be put on its
board?
A. Yes.
Q. That CTR should be made more directly useful
to the industry?
A. Yes.
Q. Was CTR so restructured, Dr. Glenn?
A. No, sir.
Q. Were company scientists put in control of CTR?
A. No, sir.
Q. Was the role of the Scientific Advisory Board
changed because of
these internal criticisms?
A. No.
Q. Was it part of CRT's charter to do research that
the companies'
scientists would find useful or helpful?
A. No.
Q. Do you believe that CRT's grant program over
the years has been
relevant to its charter, the investigation of diseases and disease
processes associated with smoking?
A. Progressively so.
Q. Does the fact that many of these projects don't
specifically say
they relate to tobacco or smoking make that research irrelevant?
A. No, sir.
Q. What I'd like you to -- to do for us is explain
--
Well before I get to it, let me ask this: Has the
type of research
focused on by the Scientific Advisory Board changed over the years
based on
your knowledge of the research that's been funded?
A. Yes, very much so.
Q. Can you explain that?
A. Well I think the best explanation is that there's
been an evolution
of scientific thought. If you go back historically and look at the
very
first medical investigations five hundred years ago, they were anatomic.
The scientists of the time were looking at gross human anatomy. Later
on
they began to focus on abnormal anatomy and diseased organs, but they
were
still looking at things grossly. It was not until the advent of the
microscope that they were able to take a microscopic look at things.
In more modern times it's been obvious that if we're
going to
understand fundamental disease we've got to know what happens within
individual cells, what happens to individual molecules, and specifically
why those cells and molecules go wrong, which is most probably related
to
immunology and genetics. So the focus of research has become more and
more
precise, more and more defined. The same thing has happened to research
sponsored by CTR that's happened in the general scientific community,
and
that is that we're focusing more and more on these fundamental processes.
In the beginning, if you look back historically
at the CTR documents,
the early studies were epidemiological, relating smoking to diseases.
There
were studies of smoke inhalation in animals, exposing animals to cigarette
smoke. They were very broad in their implication, but it didn't say
anything to why does the -- this -- this cause an abnormality. So I
think
the Scientific Advisory Board exhibited tremendous insight as they
began to
focus their research on the more molecular levels, the cellular levels,
and
in recent years the genetic level. This has been in parallel to what's
been
happening at the federal level.
*27 I'm sure you know -- all know that one of the
biggest scientific
projects facing the country today is the so-called human genome project.
What they're -- what the NIH is attempting to do --
MR. CIRESI: Your Honor, this is -- this is well
beyond the scope of
this individual's testimony.
Q. Let me ask -- let me ask you this: Is CTR funding
work in genetics?
A. Yes, sir.
Q. Immunology?
A. Yes, sir.
Q. Molecular biology?
A. Yes, sir.
Q. Microbiology?
A. Yes, sir.
Q. Virology?
A. Yes, sir.
Q. Are all of those fields relevant to the questions
you're looking at?
A. Absolutely.
Q. Has the National Institute of Health been criticized
for undertaking
basic research of this type into diseases as well?
MR. CIRESI: Your Honor, objection, it's totally
irrelevant to this
case.
THE COURT: You can answer that.
A. Yes. There has been criticism that the NIH was
not focused on broad
aspects of disease but more on basic science, and as a matter of fact,
the
director of NIH has defended this vigorously.
Q. That is to say, he's defended doing this molecular
basic research.
A. Yes.
Q. Now last week Mr. Ciresi asked you a question
based on some of your
congressional testimony. Do you remember that?
A. Yes.
Q. And you stated that he wasn't focusing on all
of your congressional
testimony. Remember that?
A. Yes, sir.
Q. Is the explanation of relevance that you've just
given consistent
with that testimony?
A. Yes, it is.
Q. Has CTR research made real and substantial contributions
to
understanding diseases and disease processes associated with smoking?
MR. CIRESI: Objection, calls for speculation, conclusion,
expert
opinion. He's not qualified.
THE COURT: Sustained.
Q. You've been scientific director of CTR?
A. Yes, I have.
Q. You've been a member of the Scientific Advisory
Board of CTR?
A. Yes, I have.
Q. And on the Scientific Advisory Board you've met
with leading
scientists in areas from throughout this country?
A. Yes, sir.
Q. Do you know whether the Scientific Advisory Board
of CTR believes
that its research has made substantial contributions to understanding
the
diseases associated with smoking and health?
MR. CIRESI: Well, same objections, and also calls
for hearsay,
speculation, conjecture.
THE COURT: Well it's --
MR. WEBER: It's a verbal act, Your Honor, and it's
obviously what
they've done as an organization.
THE COURT: Yeah. It's pretty self-serving. I think
we should move on.
BY MR. WEBER:
Q. How do you rate the overall quality of CRT's
research funded through
the SAB, Dr. Glenn?
A. I think it's outstanding.
MR. CIRESI: Your Honor -- excuse me, doctor, excuse
me. Same objection,
he's not been offered on this.
THE COURT: Okay. I'll -- I'll allow him to give
his rating.
A. I think that the track record of the SAB in selecting
research
projects has been absolutely outstanding.
Q. Let me ask you, Dr. Glenn, to turn to Exhibit
1949, which should be
in tab 28. And that's a demonstrative exhibit.
*28 A. I have it.
Q. Is that a demonstrative exhibit that relates
to what the Frank
Statement said about the TIRC?
A. Yes.
MR. WEBER: Your Honor, I'd move the introduction
of Exhibit 1949 for
demonstrative purposes.
MR. CIRESI: I have no objection to this.
THE COURT: Court will receive 1949 for demonstrative
purposes.
BY MR. WEBER:
Q. And again, this might be a little more legible
on these side
monitors than on -- on the big one.
Now this exhibit talks about what the Frank Statement
said about the
TIRC or CTR itself; correct?
A. Correct.
Q. And that portion about the TIRC is highlighted
over there on the
right.
A. Yes.
Q. Now it says that the companies are pledging aid
and assistance to
the research effort. Do you see that?
A. I do.
Q. Did that happen?
A. Yes, sir, it did.
Q. It said it was establishing a joint industry
group consisting of the
undersigned known as the TIRC. Did that happen?
A. Yes, sir.
Q. It said that in charge of the research activities
would be a
scientist of unimpeachable integrity and national repute. Did that
happen?
A. Very definitely.
Q. And who was that scientist?
A. Dr. C. C. Little.
Q. It also said there would be an Advisory Board
of scientists
disinterested in the cigarette industry. "A group of distinguished
men from
medicine, science and education will be invited to serve on this board.
These scientists will advise the committee on its research activities."
Did
that happen?
A. Yes, sir.
Q. Has there been a Scientific Advisory Board throughout
the years for
CTR?
A. There has.
Q. Are you proud of the work you've done for CTR,
Dr. Glenn?
A. Absolutely.
Q. If the grants that CTR through its SAB makes
weren't supported by
money from cigarette companies, do you think anybody would be complaining
about these grants?
MR. CIRESI: Your Honor, objection to the form of
the question.
THE COURT: Sustained.
MR. WEBER: That's all I have, Your Honor. I've got
to move a few things
though.
BY MR. CIRESI:
Q. Good morning, doctor.
A. Good morning, Mr. Ciresi.
Q. When the Frank Statement was put up there, Mr.
Weber quit reading
after the fact pledging aid and assistance to the research effort,
but then
he stopped; didn't he?
A. I don't remember.
Q. You don't remember. Well let me read the rest
of that statement,
"research effort into all phases of tobacco use and health." That was
the
pledge; correct?
A. Yes.
Q. Okay. Now today you talked about a number of
studies that were done;
correct?
A. Yes.
Q. Ones that were done here in Minnesota.
A. Yes.
Q. Tell me which one of those studies dealt directly
with smoking and
health and what was the protocol for that study.
A. I think they all dealt with smoking and health,
because we have to
understand the basic disease process.
Q. That's not what I asked, sir. Tell me which one
of those studies
felt -- or dealt specifically with smoking and health and what was
the
protocol for that study.
*29 MR. WEBER: Objection, Your Honor, it was asked
and answered.
THE COURT: It hasn't been answered. You may answer.
A. All of them.
Q. Sir, tell me the protocol for one of the studies
that dealt
specifically with smoking and health. Tell me the protocol.
A. I can't -- I can't tell you the protocol.
Q. You can't tell me the protocol for any of those
studies; can you,
sir?
A. No. No.
Q. You can't tell us the protocol for any of the
studies conducted by
the entire funding of the CTR over its 40 years; can you?
A. That's true, because the protocol is a scientific
document and I
can't repeat that to you.
Q. So you can't tell us specifically how any of
those studies, if any
of them, dealt specifically with smoking and health; can you, as you
sit
here?
A. Yes.
Q. Sir, then tell me one protocol of one study.
A. I can't tell you the protocol. I can tell you
that understanding
basic disease process is fundamental to unlocking the problem of smoking
and health.
Q. I didn't ask you about the general basic disease
process, I asked
about smoking and health.
MR. WEBER: Object to the --
Q. A specific -- excuse me. A specific protocol
for smoking and health,
can you describe it?
A. No.
MR. WEBER: Object to the introduction and -- and
the commenting, Your
Honor.
THE COURT: Okay. Try and avoid comment, counsel.
Q. Is your answer no, sir?
A. No.
Q. Thank you.
Now you talked about the members of the SAB; correct?
A. Yes.
Q. And how many of those personally have you known
over the years?
A. Well we'd have to look at the list. I don't --
I did not personally
know people who were on the Scientific Advisory Board from 1954, but
I have
known many of them over the years. All of the current members are well
known to me and many of the former members.
Q. All right. So you've known a number. Would that
be a fair statement?
A. I'm sorry?
Q. You have known a number of them. Would that be
a fair statement?
A. Yes.
Q. Okay. And you said that all of the members were
of quality; correct?
A. Yes.
Q. Of integrity; correct?
A. Yes.
Q. Cream of the crop, isn't that what you said?
A. Yes.
Q. Some were members of the National Academy of
Sciences; correct?
A. Yes.
Q. Some were Nobel Prize winners. I think you mentioned
three; correct?
A. Those were grantees.
Q. Grantees. Is that right?
A. Yes.
Q. Now when did the CTR survey all of those individuals
to determine
their opinions whether smoking caused lung cancer?
A. Never.
Q. When did they survey all of those individuals
to determine whether
or not smoking caused COPD?
A. Never.
Q. When did the CTR survey all of those eminent
scientists with respect
to whether or not smoking caused heart disease?
A. Never.
Q. When did the CTR survey all of those eminent
scientists to determine
whether they felt smoking caused oral cancer?
A. Never.
Q. When did CTR survey all of those eminent scientists
to determine
whether they felt smoking caused laryngeal cancer?
*30 A. Never.
Q. When did the CTR survey all of those eminent
scientists to determine
whether or not smoking caused esophageal cancer?
A. Never.
Q. When did the CTR survey all of those eminent
scientists to determine
whether or not they believed smoking caused kidney cancer?
A. Never. But --
Q. When did the CTR --
A. -- you have to ask --
You have to let me finish my answer, Mr. Ciresi.
Q. Sir, I only asked whether they surveyed or not,
and your answer is
no; correct? Is that correct?
A. My answer is no. But there is no point in a survey.
A survey is not
a scientific document. And every eminent scientist that you have alluded
to
certainly had his own opinions about causation and what causation
constitutes, and certainly had his own information about the statistical
relationship of smoking and other activities to the risk of developing
certain diseases, so a survey would have been naive to say the least
and
unfortunate at best.
Q. I understand you like the word "naive," sir.
You've used that
before; haven't you?
MR. WEBER: Objection to the commentary, Your Honor.
Q. Well let me just ask the question very simply.
MR. WEBER: Can I move to strike that?
THE COURT: Counsel --
MR. CIRESI: I'll withdraw it.
THE COURT: Withdraw it. All right.
Q. You've used the word "naive" before; correct?
A. Yes.
Q. Now, when did the CTR survey all of their eminent
scientists as to
whether or not smoking caused bladder cancer?
A. Never.
Q. When did the CTR survey all of their eminent
scientists to determine
whether or not smoking caused pancreatic -- pancreatic cancer?
A. Never.
Q. When did the officials, the executive officers
of the defendant
manufacturing companies, come to the CTR and say, "We think there's
a
controversy. Let's get these eminent scientists in and we, the CEOs
of the
company, want to hear what they say?" When did they do that?
A. Never.
Q. When did the CEOs of any of these companies ever
say, "Please go out
to these eminent scientists and find out whether they believe, based
on all
of their research, that smoking causes any of the diseases that I just
asked you about?" When did they do that, sir?
A. Never, because the term "causation" was inappropriate.
Q. We'll get to that, sir.
MR. WEBER: Object to that again, and move to strike
it, Your Honor.
MR. CIRESI: Well, Your Honor, that wasn't --
MR. WEBER: It's continuing.
THE COURT: I'll allow that comment.
Q. When did the CEOs of any of these companies come
up to you and say,
"How much money that we've given to CTR has specifically been spent
on
smoking-and-health-related research?"
A. They haven't asked that question because they
know that all of the
money has been devoted to that issue.
Q. They've never asked you that; have they, sir?
A. No, sir.
Q. Not any scientist from any of those companies
has ever asked you;
have they?
A. No, sir, because they are well aware that we
are directing our
attention to the fundamental disease processes associated with smoking.
*31 Q. And what you said on Friday with regard to
these grants was that
they're generally in the area of 80 to 85 thousand dollars, and they
allow
young people just getting started to get their feet wet. Isn't that
what
you said?
A. That's correct.
Q. And the vast majority of these grants of CTR
have been to young
people just getting their feet wet; --
A. No.
Q. -- correct?
A. I didn't say that. I said these grants -- these
grants have allowed
young people to get a start, but we've also funded well-established
investigators, such as the Nobel Prize winners that I've told you about.
Q. Well let me direct your attention to page 4775,
when you were
talking about the pages of the grants on an exhibit that was shown
to you
by counsel, and you said as follows: "And the amount of the award is
listed
there, and I would tell you that our average award is something like
80 or
85 thousand dollars a year."
A. That's correct.
Q. "So they're not huge grants. But they are very
good grants,
especially for young people who are just getting their -- their feet
wet."
Is that what you said?
A. Yes, sir.
MR. WEBER: Objection, Your Honor, it's an improper
use of a deposition.
It's not inconsistent.
THE COURT: Sustained.
BY MR. CIRESI:
Q. Now, how many of the CTR awards were for people
just getting their
feet wet? How many?
A. I can't tell you a specific number, but a substantial
number. The
point I was making is that a grant of this magnitude is of extreme
value to
someone who is just getting started in the biomedical research field.
Q. And sir, have you done a survey to determine
how many of these
awards were to people just getting their feet wet?
A. No. We've never done a tabulation.
Q. Have you, in the time you've been with the CTR
--
You've testified a number of occasions; correct?
A. No.
Q. How many times have you testified in your life,
40 times?
A. Perhaps.
Q. Okay. Now in the entire time that you've been
with the CTR, have you
gone out and asked the grantees who are doing the work, "Do you believe
this related to smoking and health?" Have you done that?
A. No, sir.
Q. Have you directed anyone at the CTR to do that,
sir?
A. No, sir.
Q. Have the defendants asked the CTR to ever do
that?
A. No.
Q. Now you talk --
You talked about risks; did you not, sir? The risks
for -- I think you
talked about high cholesterol for heart disease and -- you remember
that
testimony?
A. Yes.
Q. And you were talking about various risk factors;
is that right?
A. Yes.
. I want to hand you the 1989 Surgeon General's report.
MR. CIRESI: May I approach, Your Honor?
THE COURT: All right.
(Document handed to the
witness.)
Q. I'll hand you the entire report, sir, if you
want to look anyplace
to make sure it's in context, and also a part of it.
MR. WEBER: Do you have an exhibit number on that,
Mr. Ciresi?
MR. CIRESI: The 1989 is Exhibit 3821.
*32 MR. WEBER: Thank you.
BY MR. CIRESI:
Q. Now on page 160, is there an estimated risk of
various activities?
A. Yes, there is.
Q. And do you know what that's for, sir?
A. This says "Table 13, Estimated Risk of Various
Activities," and then
it lists activities or cause, and then annual fatalities per one million
exposed persons.
Q. Is that for lung cancer?
A. No, this is in general. It's for a variety of
activities.
Q. Do you know what --
So it's for a variety of activities and which activities
cause death;
correct?
A. Not necessarily cause. It says activity or cause.
Q. Okay.
A. And then it lists the fatalities associated with
that risk.
Q. Now let's take a look, then, at that Table 13.
MR. WEBER: I'm going to object to any questions
about this, Your Honor.
Dr. Glenn testified about risk factors, not about risks of comparable
activities. This is beyond the scope of what -- what his testimony
was.
THE COURT: No, I think that's within the scope.
BY MR. CIRESI:
Q. Now sir, on the left-hand margin it says "Activity
or cause;"
correct?
A. Correct.
Q. And then it has "Annual fatalities for 1 million
exposed persons."
Correct?
A. Yes.
Q. And for active smoking it was 7,000; correct?
A. That's correct.
Q. And for alcohol totally it was 541, 275 by accident
and 266 by
disease; correct?
A. Yes.
Q. And then it went all the way down through work,
swimming, football,
electrocution, et cetera; correct?
A. Yes.
Q. Now when we talk about cause, doctor, last week
we talked about the
Henle Koch postulates; didn't we?
Q. Yes.
Q. And today when you were talking about cause,
you were talking about
universality. Do you remember that word you used?
A. Yes.
Q. And by that you meant that every time someone
was exposed to
something, universally a disease would be produced, according to Henle
Koch; correct?
A. No, I didn't say according to Henle Koch. I talked
about the
universality of risk factors.
Q. You were talking about universality of risk factors
then?
A. Yes.
Q. Is that what you were saying?
A. Yes.
Q. Well the Henle Koch postulates were based on
19th century medical
science; weren't they?
A. Yes.
Q. And we went through those last week; didn't we,
sir?
A. Yes.
Q. And we found that you yourself believed that
certain viruses would
cause a disease regardless of whether they met Henle Koch postulates;
didn't you?
A. Yes.
Q. And one of those was Epstein-Barr; right?
A. Yes.
Q. Your judgment was that caused infectious mononucleosis;
correct?
A. It has been so stated, yes.
Q. And you agreed with that; didn't you?
A. Yes.
Q. It was a cause of infectious mononucleosis; correct?
A. Yes.
Q. How many other causes of infectious mononucleosis
are there, sir?
A. I don't know.
Q. Many, aren't there?
A. Yes.
Q. All kinds of causes of infectious mononucleosis;
correct?
*33 A. As I understand it, yes.
Q. Do you know how many cases of infectious mononucleosis
are caused by
Epstein-Barr?
A. No.
Q. Do you know how many are caused by the other
causes?
A. No.
Q. But you used the word "cause" in that effect;
don't you, sir?
A. I accept your use of the term "cause" in the
lay sense.
Q. And the medical scientists accept that; don't
they, sir?
A. In the lay sense, yes.
Q. Not in the lay sense. Werner Henle, who found
the Epstein-Barr virus
as a cause of infectious mononucleosis, used it in a medical sense;
didn't
he, sir?
A. I don't know.
Q. You just don't know.
A. No.
Q. Okay. Do you know how many cases of lung cancer
are caused by
smoking as contrasted with any other cause?
A. I accept the word "cause" in the lay sense, and
I don't know the
answer.
Q. You don't. But you do know that the attorney
-- or excuse me, the
Surgeon General since 1964 has used the word "cause;" correct?
A. Yes.
Q. And explained the word "cause" in the Surgeon
General's report;
correct?
A. Yes.
Q. And went and talked about the experimental approach
accepted by
scientists which provides a direct method for establishing whether
an
association is causal; correct?
A. I don't follow your question.
Q. The Surgeon General in the 1964 report set forth
the experimental
approach which provides a direct method for establishing whether
association is causal; didn't he?
A. There is the argument and the discussion of cause,
causation, risk,
and so forth, yes.
Q. He talks about the temporal association; correct?
A. Yes.
Q. The consistency of the association.
A. I guess, yes.
Q. Do you know?
A. I don't know.
Q. Have you read the Surgeon General's report?
A. The consistency, I don't -- I can't answer that.
That's the part of
your question I can't answer.
Q. So -- so you don't know whether that's a factor
or not; is that
right?
A. Correct.
Q. Okay. Do you know if the strength of an association
is?
A. Roughly.
Q. Do you know?
A. Roughly.
Q. I didn't ask you roughly or vaguely. Do you know?
A. Roughly.
Q. Just roughly. Well remember last week you said
that you don't guess,
you either know or don't know? Isn't that your sworn testimony?
A. Correct.
Q. Do you know or not know?
A. I roughly know that strength of association.
Q. Okay.
A. I'm not a statistician.
Q. Do you know if coherence is a factor used by
medical scientists to
determine causation?
A. I think so.
Q. All right. Do you know if the specificity of
an association is used
by medical scientists to determine causation?
A. Yes.
Q. And sir, you are aware, are you not, that the
Surgeon General in
1964 and since that time has used all of those factors to say from
a
scientific standpoint there's a cause-and-effect relationship between
smoking and lung cancer?
A. Yes.
Q. And you know that eminent scientists from around
the world said the
same thing; don't you?
*34 A. Yes.
Q. Using that scientific methodology to determine
cause and effect;
correct?
A. Yes.
Q. Now what was being argued about in Exhibit 11028
was what method you
would use to determine causation, direct or indirect; isn't that right?
A. I don't remember that document.
Q. Mr. Weber just showed it to you this morning.
Remember, he said it's
the one I showed you last week?
A. I didn't -- I didn't memorize the numbers of
the documents, Mr.
Ciresi.
Q. That was the --
That's fair enough, doctor. That's the one that
-- where the three
scientists came over from England and met with members of the industry
and
met with all of those scientific organizations. Do you recall that
one?
A. Yes.
Q. Okay. If you would direct your attention to Exhibit
11028. It would
be in volume two, sir.
A. It would be volume two, yes.
Q. Volume two.
A. And it is 11 --
Q. 028.
A. I have it.
Q. All right. And you'll recall that Mr. Weber took
you through a
number of pages?
A. Yes.
Q. First of all, let's start with page 492.
A. All right.
Q. Now do you recall, sir, that last week we went
over this page?
A. Yes.
Q. And the next page; didn't we?
Q. Yes.
Q. And you'll recall that last week I went over
with you, first of all,
that first paragraph.
A. Yes.
Q. It pointed out that "With one exception," and
that was the scientist
from Yale, "the individuals whom we met on that trip believed that
smoking
causes lung cancer if by 'causation' we mean any chain of events which
leads finally to lung cancer and which involves smoking as an indispensable
link;" correct?
A. I remember seeing that, but I also remember seeing
further on in the
document that they refute their own statement --
Q. Well --
A. -- because other -- other -- other experts equivocated.
Q. Excuse me, sir. Remember that we saw this last
-- last week?
A. I do.
Q. Okay. And we also looked at the bottom of that
page; didn't we, sir?
A. Yes.
Q. Last week.
A. Yes.
Q. And we looked at this part about "The SAB of
TIRC and the group we
met at the National Cancer Institute, in Bethesda, broadly take the
view
that causation is likely to be indirect;" correct?
A. Yes.
Q. So that of all the people that were met there,
and that's reported
later in this document, there was universality -- universality on the
fact
that smoking caused cancer, but some thought it was direct and some
thought
it was indirect, --
A. That's not --
Q. -- with the exception of --
A. That's not corroborated by the document. If you
read further you'll
see there's a great deal of equivocation.
Q. Well let's go on. We're going to go through that
and see. "The SAB
of TIRC and the group we met at the National Cancer Institute, Bethesda,
broadly take the view that causation is likely to be indirect." That's
what
it says; correct?
A. Correct.
Q. "Several hypothetical means by which this" --
and that's the
indirect method; correct? That's what's being referred to there.
*35 A. I assume.
Q. Okay. "Several hypothetical means by which this
could occur were
proposed but with no experimental evidence to support any of them."
Correct?
A. That's what it says.
Q. Over on the next page then. "Otherwise we found
general acceptance
of the view that the most likely means of causation is that tobacco
smoke
contains carcinogenic substances present in sufficient quantity to
provide
lung cancer when acting for a long time in a sensitive individual."
Correct?
A. That is the statement.
Q. All right. So that some people felt it was direct,
some people felt
it was indirect, based on these two pages; correct?
A. I don't know whether it's correct or not. That's
what's written.
Q. Okay. Now they said that also they felt there
was carcinogenic
substances present in the tobacco smoke; correct?
A. I believe at that time many people believed that.
Q. And it's known there's carcinogenic substances
in cigarette smoke;
isn't it? Even today it's known now; isn't it?
A. I'm sorry, I missed your --
Q. It is known today that there are carcinogenic
substances in tobacco
smoke; correct?
A. It is -- it is known today that there are minute
quantities of
carcinogens in tobacco smoke. Yes.
Q. And -- and that was known by some of these defendants,
as we saw,
back in the early fifties; correct?
A. That is what the documents state.
Q. And the Surgeon General has reported that in
many of the Surgeon
General reports; correct?
A. As I understand, yes.
Q. And the Surgeon General reports have talked about
the synergism
between all of the carcinogens, not just one like benzopyrene; haven't
they?
A. Yes.
Q. And the medical literature has talked about the
synergisms of all of
the carcinogens in tobacco smoke; --
A. Yes.
Q. -- hasn't it?
And in this particular document there's reference
to the synergism of
all of the carcinogens in tobacco smoke; isn't there?
A. I don't remember it in this document.
Q. You remember about the conclusion, I believe
it was number three --
may have been six, I can't recall right now -- that talked about the
fact
that there was no super carcinogen? Do you remember that?
A. Yes.
Q. It is number three. If you take a look at page
nine, sir.
A. All right.
Q. It says, "The direct carcinogenicity of smoke
condensate to animal
tissue, which is consistent with direct causation, is now fully confirmed
but the evidence so far obtained makes it unlikely that this activity
is
due to any single 'super carcinogen' in smoke." Correct?
A. That's what is written, yes.
Q. And you understand that to mean, sir, that there
are many
carcinogens in tobacco smoke; don't you?
A. Yes.
Q. And they work in synergism; correct?
A. It does not say that, Mr. Ciresi. And this statement
made 40 years
ago made the assumption that a direct effect of tobacco smoke or tobacco
smoke condensates was the cause of lung cancer, and that's since been
shown
to be an incomplete answer.
*36 Q. Didn't say it was the only cause; does it?
Does it say that?
A. You are using "the cause of lung cancer."
Q. Did you ever hear me in any of my questions over
two and a half days
ask you whether it was the only thing that ever caused lung cancer?
Did I
ever say that, sir?
A. I don't --
MR. WEBER: Objection, Your Honor.
A. I don't know that.
MR. WEBER: That's argumentative.
THE COURT: No, you may answer that.
Q. I never said that; did I, sir?
A. I don't know, Mr. Ciresi.
Q. Well did you ever hear me say that?
A. I don't know that I heard you say that.
Q. Now --
And they're not saying here that it is the only
cause of lung cancer;
are they? They're saying it's a cause of lung cancer; are they not?
A. I don't know what they're saying, Mr. Ciresi.
They're talking about
smoke condensates 40 years ago, and they are trying to determine whether
there are carcinogens that are actually effective, I think.
Q. So you just don't know whether they're talking
about smoking as a
cause of lung cancer or smoking as the only cause in the entire world
of
lung cancer; is that right?
A. I don't know.
Q. Now when Mr. Weber was taking you through this
exhibit, he took you
up to page 497. And actually to be fair, he started at 496. Can you
turn to
496, please.
You remember he started at the bottom here, he directed
your attention
down to "Others, including the SAB" --
A. Yes.
Q. -- "and a group at the National Cancer Institute,
do not accept that
a case has yet been made that tobacco smoke is directly carcinogenic
to the
human lung." Remember that?
A. Yes.
Q. And that goes back to the page we just saw where
they were talking
about the TIRC and direct and indirect; doesn't it?
A. I guess.
Q. "While accepting broadly that cigarette smoke
may be said to be
capable of 'causing' lung cancer they argue that the evidence favors
some
indirect mechanism of causation." Do you see that?
A. That --
It is written, yes.
Q. And by "they" who favor the indirect causation
approach, that's
reference to the National Institutes of Health and the TIRC; correct?
A. I believe so.
Q. And then you read through that paragraph; correct?
A. Yes.
Q. And then you stopped at the end of that paragraph;
didn't you?
A. I think so, Mr. Ciresi.
Q. And at the very next paragraph, sir, it reads,
"The group at the
National Cancer Institute despite their lack of conviction of a direct
causal relationship nevertheless advised that the tobacco industry
must
concern itself permanently with the problem of the biological effect
of
smoking." Correct?
A. Yes.
Q. They were saying they had to do direct smoking-
related research;
correct?
A. No, it did not say that.
Q. They didn't say that. You don't think that means
that.
A. Didn't say that.
Q. "...the tobacco industry must concern itself
permanently with the
problem of the biological effects of smoking." What do you think the
biological effects of smoking are, sir? If you know.
*37 A. I think that's a very broad question. If
you will ask me
specifically, I'll try to answer.
Q. Can you answer the question as it is posed? If
you can't, just tell
me you can't.
A. No.
Q. All right. So you do not understand what "the
biological effects of
smoking" would be.
A. Yes, I do.
Q. Can cancer be a biological effect?
A. Many things could be a biological effect.
Q. I didn't ask you if many things could be. I asked
you if cancer
could be a biological effect.
A. I think you could use that term.
Q. Can heart disease be a biological effect?
A. Yes.
Q. Can chronic obstructive pulmonary disease be
a biological effect?
A. Yes.
Q. Okay. Now in the paragraph up above that you
did read, it says that
"Unfortunately so long as the basic problems underlying the transformation
of a normal to a cancerous cell remain unsolved, theories of direct
causation must be largely -- largely speculative and almost without
exception incapable of being tested experimentally." Correct?
A. No.
Q. Isn't that what it reads? Did I misread it?
A. Yes.
Q. "...and almost without exception incapable,"
I'm sorry, "of being
tested experimentally." Correct?
A. I accept your correction.
Q. Okay. And do you know if there were inhalation
tests done that
confirmed in the industry's judgment the direct causation?
MR. WEBER: Your Honor, let me object because --
just so the record's
clear, according to the realtime transcript the reference in the document
is to "indirect," and what Mr. Ciresi said was "direct," and I -- just
so
it's clear.
MR. CIRESI: I believe I corrected it.
THE COURT: He -- it's been corrected, I believe.
MR. WEBER: I thought you corrected a different issue.
But -- but with
that, go ahead. I'm sorry for the interruption.
Q. Well let me --
Just so the record's perfectly clear, doctor, I'll
read it again.
"Unfortunately so long as the basic problems underlying the transformation
of a normal to a cancerous cell remain unsolved, theories of indirect
causation must be largely speculative and almost without exception
incapable of being tested experimentally." Have I read that correctly?
A. You did.
Q. Okay. And the indirect causation was the theory
being espoused by
the TIRC at that time; correct?
A. I don't think that it was a theory being espoused
by the TIRC. I
think that this statement is -- is prophetic in a way because it
acknowledges that cause and risk factors of lung cancer are -- were
still
unknown and they -- they still are not clear today. But it -- this
is an
acknowledgment that the sort of research that has to be undertaken
has to
address both direct and indirect factors.
Q. Sir, --
A. And --
Q. -- the theory being espoused in this document
as reported by the
TIRC was indirect causation; correct?
A. Mr. Ciresi, as a matter of common courtesy I
don't interrupt you.
Q. Well I'm not going to say anything in regard
to that, sir.
*38 My question is very simple. All right? The record
will reflect
whether I interrupted you or you interrupted me. If I did, I apologize.
Now
please listen to my question and I will restate it.
Is it reported that, in this document, that the
TIRC was advocating a
theory of indirect causation? "Yes" or "no."
A. Yes.
Q. Thank you.
Now do you know if the industry was aware of tests
which they believed
confirmed -- animal tests that confirmed causation?
A. No, I'm not aware of that, because no animal
experiments, inhalation
experiments had ever demonstrated this.
Q. Never have; correct?
A. To my knowledge, never.
Q. All right. Can you direct your attention, sir
--
THE COURT: Mr. Ciresi, I wonder if we should recess
for lunch.
MR. CIRESI: If it's an appropriate time, Your Honor.
THE COURT: Okay. We'll recess for lunch and reconvene
at 10 minutes to
2:00.
THE CLERK: Court stands in recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Counsel.
MR. CIRESI: Thank you, Your Honor.
Good afternoon, ladies and gentlemen.
(Collective "Good afternoon.")
BY MR. CIRESI:
Q. Good afternoon, doctor.
A. Good afternoon, sir.
Q. Now doctor, when we broke you said you were --
I think you said
never, to your knowledge, had animal experiments, inhalation experiments,
ever demonstrated that smoking caused lung cancer; correct?
A. Correct.
Q. Can you direct your attention, please, to Exhibit
21905, which would
be in volume two.
A. Yes, sir, I see that.
Q. All right. This is a document that's already
in evidence.
Have you seen this document before, doctor?
A. I'm not sure, Mr. Ciresi. I may have in times
past.
Q. This is a document of Gallaher Limited which
was a company of
American Tobacco, it's dated April 3rd, 1970, and the subject is the
"Auerbach/Hammond Beagle Experiment." Do you see that?
A. Yes.
MR. BERNICK: Your Honor, object. He said Gallaher
was part of American
Tobacco. That's just not so. It's an affiliate of American Tobacco.
It was
owned by American Brands.
MR. CIRESI: And American Brands owned American Tobacco
and Gallaher.
Q. Now when you looked at this document before,
did you ascertain
whether it had been provided to American?
A. I'm not sure I saw this, Mr. Ciresi, but I'd
be happy to try to
respond.
Q. Okay. Now do you know if the Auerbach work was
funded by CTR?
A. No, I don't believe it was.
Q. Do you know if CTR funded work at Battelle?
A. Yes.
Q. And do you know if Battelle conducted animal
inhalation tests?
A. I believe so, yes.
Q. And do you know if they confirmed what Dr. Auerbach
found?
A. If they confirmed what Dr. Auerbach --
Q. Found.
A. -- found. You'd have to tell me what he found.
Q. Well do you know anything about the Auerbach
studies on beagles?
A. I know something about it.
Q. Do you know if the same type of tests were conducted
by Battelle,
funded by CTR, which found the same things that Dr. Auerbach found?
"Yes"
or "no" or you don't know.
A. I don't know.
Q. Okay. Now can you direct your attention, sir,
to page two of this
exhibit. You do see the subject is the Auerbach-Hammond beagle experiment;
correct?
*2 A. Yes.
Q. All right. And on page two, number three, it
is stated there by the
general manager of research for Gallaher in a memo that was directed
to the
general manager -- or excuse me, the managing director as follows:
"However, in spite of the qualifications in one and two, we believe
that
the Auerbach work proves -- proves beyond reasonable doubt that fresh
whole
cigarette smoke is carcinogenic to dog lungs and therefore it is highly
likely that it is carcinogenic to human lungs." Do you see that?
A. I see that.
Q. He goes on to state, "It is obviously impossible
to be certain of
the extrapolation from an animal lung to a human lung, but we have
to bear
in mind that the anatomy of a dog is relatively close to human anatomy
and
the type of tumor found in the dog was the same type as found in heavy
smokers." Do you see that?
A. I see that.
Q. Were you aware of this?
A. I -- I'm aware of -- of Dr. Auerbach's interpretation,
but it was
subsequently refuted.
Q. Sir, were you aware of this finding by Dr. Auerbach?
A. I'm not sure this was a finding, because the
-- it subsequently did
not hold up to scrutiny.
Q. Are you aware that Gallahers felt it was beyond
a reasonable doubt
that it proved --
A. I see that statement by the scientist at -- at
Gallaher.
Q. Can you go on, then, to the last page of this
document.
A. Yes, sir.
Q. And do you see in the last paragraph, Mr. Tughan
states as follows,
"Apart from Auerbach's work, Dontenwill's work and the preliminary
results
from Harrogate all point to the fact that under suitable conditions
fresh
whole smoke inhalation in animals will produce pre-cancerous changes
and,
in certain instances, true cancers which are similar to those found
in
human smokers." Do you see that?
A. I see that statement, yes.
Q. Are you aware of the -- of Dontenwill's work?
A. No, I'm not familiar with that.
Q. Are you --
Are you familiar with the work done at Harrogate?
A. No.
Q. You know that Harrogate was a research laboratory
in England set up
by the tobacco industry?
A. Yes.
Q. Has anybody ever provided you with that information?
A. No.
Q. Mr. Tughan goes on to state then, "It therefore
seems to us it is
more than coincidence that experimental evidence is building up in
this
direction from several independent research organizations, each of
which is
of very high caliber." Do you see that?
A. I see that.
Q. And you're not aware of any of that work; are
you, sir?
A. I'm not aware of --
Q. Any of that work.
A. I'm not aware of any of the work from Dontenwill
or Harrogate, no.
Q. Okay. Can you turn back one page, then, and look
at number five.
A. Yes, sir.
Q. "Although the results of the research would appear
to us to remove
the controversy regarding the causation of the majority of human lung
cancer, it" --
A. Excuse me, sir, number five says "Unfortunately"
--
Q. I'm sorry, six.
*3 A. -- "the research" --
Q. I'm sorry, sir, number six.
"Although the results of the research would appear
to us to remove the
controversy regarding the causation of the majority of human lung cancer,
it does not help us directly with the problem of how to modify our
cigarettes." Do you see that?
A. I do.
Q. And the problem of how to modify the cigarettes
is that there were a
number of carcinogens in cigarettes; isn't that correct?
A. It doesn't say that. It just says "it doesn't
help us directly with
the problem of how to modify our cigarettes."
Q. Sir, have you come to learn over the period of
time that you've been
with the CTR, or indeed before that, that there were a number of
carcinogens in cigarette smoke?
A. Yes.
Q. And did anybody ever tell you that the cigarette
companies could
remove one and not the other?
A. No.
Q. Did they ever tell you they could remove all
of them?
A. No.
Q. Do you know of any attempt they made to remove
all of them?
A. No.
Q. Have you ever seen any studies they conducted
trying to remove all
of the carcinogens?
A. No.
Q. In your discussions with Dr. Spears did you ever
ask him, "Have you
ever tried to remove the carcinogens?"
A. No.
Q. Have you ever had that discussion with anyone
--
A. No.
Q. -- at any of the companies?
A. No.
Q. Did you ever have that discussion with any member
of the SAB board?
A. No.
Q. Can you direct your attention, then, sir, to
Exhibit 10312, which
would be in volume one. This is a Philip Morris document dated February
5th, 1970 from Mr. Saleeby, who was a scientist at Philip Morris, to
the
senior vice- president and a member of the board of directors, Mr.
Landay.
Have you seen this before?
A. I'm sorry, sir, I can't find it. It's 10212?
Q. I'm sorry, 10312. And I apologize, I thought
you had it, sir.
A. Thank you.
Q. Do you have it now?
A. Yes.
Q. Okay. And do you see that it's directed to Mr.
Landay?
A. Yes, I can read that.
Q. And it's from Mr. Saleeby?
A. Saleeby.
Q. Saleeby. Did you know Mr. Saleeby?
A. No.
Q. And in the first paragraph, do you see the sentence
that starts,
about halfway through it, "The important finding is that two of the
86 dogs
which started the test developed 'early squamous cell bronchial carcinoma"'
--
Do you see that?
A. I do.
Q. -- "i.e., the most common lung cancer occurring
in man." Correct?
A. Yes.
Q. And do you know if that was the most common lung
cancer occurring in
man at that time?
A. Yes.
Q. Is it today?
A. Yes, it still is.
Q. And do you see where it's then reported, "This
is the first time
that cigarette smoke as a direct agent has produced lung cancer in
any
animal in any reliably conducted experiment?"
A. I see that.
Q. So we see that Philip Morris felt that Auerbach-Hammond
was
reliable; correct?
A. Well I would say that Mr. Saleeby felt that.
*4 Q. And he was reporting to the senior vice-president
and member of
the board of directors of the company; correct, sir?
A. I will accept that. I didn't know Mr. Landay.
Q. And can you direct your attention to Exhibit
12296, which is back in
volume two, sir.
A. I have that.
Q. This is a memo on RJR header -- letterhead. Do
you see that?
A. I see that.
Q. Dated December 22nd, 1971?
A. Yes.
Q. Subject: "Meeting at Council for Tobacco Research,
December 21,
1971;" correct?
A. Correct.
MR. CIRESI: Your Honor, we'd offer Exhibit 12296.
MR. WEBER: No objection, Your Honor.
THE COURT: Court will receive 12296.
THE REPORTER: I don't think we have it.
THE COURT: What?
THE REPORTER: I don't think we have it.
BY MR. CIRESI:
Q. Now this is a report of a meeting that was held
at the CTR to
discuss the Auerbach -- Auerbach smoking experiments on dogs; correct?
A. Yes.
Q. Have you seen this before, sir?
A. Yes.
Q. When did you first see it?
A. Probably a year ago.
Q. Who provided it to you?
A. I -- I can't recall. It was in connection with
a previous
deposition.
Q. Okay. Now you see that present at the meeting
were three individuals
from The Council for Tobacco Research?
A. Yes.
Q. Mr. Lisanti?
A. Dr. Lisanti.
Q. He's a doctor; is that right?
A. Yes.
Q. Associate research director?
A. Yes.
Q. Okay. Mr. Hoyt, who was the executive director
of The Council for
Tobacco Research?
A. I don't know what his title was in 1971, but
he was the executive
officer.
Q. And Robert C. Hockett, who was the associate
scientific director?
A. Dr. Hockett was the associate scientific director.
Q. And there's three individuals present from Philip
Morris; correct?
A. Yes.
Q. Mr. Holtzman?
A. Yes.
Q. Mr. Saleeby. Same Mr. Saleeby; correct?
A. Yes.
Q. And Dr. Helmut Wakeham, who was the vice-president
of research and
development; correct?
A. Yes.
Q. Mr. Holtzman was an in-house lawyer; wasn't he?
A. I -- I believe Mr. Holtzman was an attorney.
Q. And from RJR was an in-house lawyer, Mr. Roemer,
and Dr. Murray
Senkus, who was head of research and development; correct?
A. I will accept that. I don't know that.
Q. Do you know if Mr. Roemer was an in-house lawyer?
A. I don't know that, no, sir.
Q. Okay. Now do you see here that there was -- in
the "Background,"
that the National Cancer Institute under the direction of Gio Gori
was
negotiating with Dr. Auerbach to conduct further smoking experiments
on
dogs?
A. I see that.
Q. And the objective in that experiment was to determine
the effect of
nicotine on smoking dogs; correct?
A. That is what is stated.
Q. And the Scientific Advisory Board had met on
December 10th to 12th
of 1971 regarding that; correct?
A. It so states, yes.
Q. And they were looking at this proposed study
on nicotine and they
felt it would be meaningless from a medical standpoint; is that right?
*5 A. Yes.
Q. And that we should make every effort to convince
NCI to abandon the
experiment; correct?
A. Right.
Q. And "we" was the CTR and the companies; correct?
A. I guess so, yes.
Q. Okay. And then he sets forth in this report,
Mr. Vassallo, who was a
vice-president of research and development for RJR -- I'm sorry, I
misspoke, sir.
Dr. Senkus sets forth in this report the basis for
the attempt to
convince the NCI not to conduct this experiment on nicotine; correct?
A. Yes.
Q. And the reasoning went as follows: "Smoke will
be delivered to the
-- to the dogs through an incision in the throat, thus whole smoke
will be
presented to the lungs. During human smoking, smoke is first presented
to
the mouth where the aldehydes are removed from the smoke." Do you see
that?
A. I do.
Q. What's an aldehyde?
A. A chemical compound that can be very irritating.
Q. What kind of chemical compound?
A. Well aldehydes -- formaldehyde is an aldehyde.
Q. Do you know its biological -- its chemistry,
its chemical
composition, sir?
A. No, I can't give you the chemical formula. But
formaldehyde is the
aldehyde of formic acid. It is a degratory product.
Q. But you do not know the chemical composition;
correct?
A. No, sir.
Q. And sir, are you aware of any study conducted
by CTR or these
companies, Philip Morris or RJR, which would suggest, imply, or lead
one to
the conclusion that aldehydes are selectively selected out in the mouth
during smoking?
A. I can't cite any studies. It so states here,
but I don't have any
personal knowledge of this, no.
Q. You've never heard of any such thing; have you?
Any such study?
A. Well I don't know whether I have or not. It seems
vaguely familiar,
but I -- I don't know that I know that.
Q. What seems vaguely familiar?
A. That aldehydes are detoxified. But I don't know
that. I simply don't
know.
Q. Okay. So this again is not something you would
guess at. You either
know or don't know; correct, sir?
A. Yes.
Q. Okay. At least you can't help us by pointing
to any study that would
ever suggest, imply, or direct one to the conclusion that aldehydes
are
selectively removed in the mouth; correct?
MR. WEBER: Objection, Your Honor, that's been asked
and answered, that
very question.
THE COURT: It's been asked and answered.
BY MR. CIRESI:
Q. Now sir, if aldehydes are not selectively removed
in the mouth, then
the smoke wouldn't be any different inhaled through the mouth as inserted
through an incision in the throat; isn't that correct?
A. I don't --
I can't say that, no. I don't know that.
Q. You don't know. By that you mean you don't know
one way or the
other; correct, sir?
A. I don't know one way or the other.
Q. Now do you know if the CTR and Reynolds and Philip
Morris went to
the NCI and attempted to convince them not to conduct this study on
nicotine?
A. I don't know.
Q. Do you know if Dr. Gori agreed to meet with them?
*6 A. It says so in the memorandum.
Q. The next page; doesn't it?
A. Yes.
Q. And Dr. Gori was with the NCI; isn't that right?
A. Yes.
Q. And do you know if Dr. Gori was a consultant
to the tobacco
industry?
A. No, I don't know that.
Q. Do you know if they ever paid him any money?
A. I don't know.
Q. Do you know if he ever asked them to suggest
that he head up a
Tobacco Working Group?
A. I don't know.
Q. Do you know if they asked him to lobby -- if
he asked them to lobby
the White House on his behalf?
MR. WEBER: Objection, Your Honor, this is argumentative
and there's no
foundation for it.
THE COURT: Well he can answer it if he knows.
Q. Do you know?
A. I don't know.
Q. Do you know how many studies, sir, confirmed
the Auerbach studies,
at Harrogate, Dontenwill or anyplace else?
A. My information is that none of them confirmed
Dr. Auerbach's
conclusions.
Q. Do you know how many at Harrogate or from Dontenwill
or anyplace
else confirmed it?
A. No.
Q. Do you know?
No?
A. No.
Q. Can you direct your attention, then, back to
Exhibit 11027, which
would be the last exhibit in volume one. And you were directed there
by Mr.
Weber. Do you recall that document?
A. Yes.
Q. Marked "CONFIDENTIAL." It was one of the Tobacco
Standing Committee,
which was a research arm of The Tobacco Research Council in England?
A. Yes.
Q. Okay. And it dealt with discussions with various
research directors
of the cigarette companies. Do you remember that?
A. It is a report on research into smoking and health.
Q. And it relates to a trip to the United States
in September and
October of 1964; correct?
A. It so states.
Q. And Mr. Weber asked you to read from a number
of the pages here. Do
you recall that?
A. Yes.
Q. He had directed your attention, I believe, to
page 290 and asked you
to start there under "A.M.A Research into Smoking and Health," and
you read
on for a few pages. Do you remember that?
A. Yes.
Q. Do you know whatever happened to that AMA research?
A. Well ultimately the agreement between the American
Medical
Association and the tobacco companies came to an end. I don't know
why.
Q. Do you know if the tobacco industry pulled the
funding from the AMA?
A. I don't know.
Q. Can you direct your attention, then, to page
-- you --
You read through page 290 and 291, and then you
went over to 292. Do
you remember that, sir?
A. Yes.
Q. Okay. Can you go to 292 where you stopped. You
remember Mr. Weber
asked you to read paragraph two.
If we could move it down just a little bit, Ms.
Sutton. Thank you.
You read paragraph two, main reason why people smoke
is the nicotine.
Do you see that?
A. Yes.
Q. Now Dr. Seevers, he was doing research on nicotine;
wasn't he?
A. I believe so.
Q. He wasn't researching into lung cancer; was he?
A. No.
Q. No. And he found nicotine addictive; didn't he?
*7 A. I think that that was his conclusion, yes.
Q. And that's set forth in all the paragraphs that
you didn't read
there, paragraph three, paragraph four, paragraph five, paragraphs
six and
seven. You go over to the next page, the addictive experiments with
monkeys
that were being conducted. Did you read all those paragraphs?
A. No, sir.
Q. Did anybody direct you to those to read?
A. No, sir.
Q. Okay. And then you went on to the last page and
you read Dr.
Seevers' comments about the Surgeon General's Advisory Committee; correct?
A. Yes.
Q. And I believe you said that -- or Mr. Weber said
that Dr. Seevers
said it was a committee of prima donnas; is that right?
A. That was what was written, yes.
Q. Have you ever known a doctor to be a prima donna?
A. Yes, sir.
Q. Have you?
A. Yes, sir.
Q. Now did you consider all of the members of the
Surgeon General's
committee in 1964 prima donnas, all those eminent physicians that were
on
there?
A. Well I only knew one of them on the -- on that
committee at that
time.
Q. Who did you know?
A. Dr. John Hickham, who was one of my teachers.
Q. Did you think he was a prima donna?
A. No, sir.
Q. No. Did you think all the doctors on the 1967
and 1968 and 1969 and
1971 or 1972 or 1973 or '74 or '75 or '76, or any of the Surgeon General's
reports all the way up through 1994, did you think they were all prima
donnas?
MR. WEBER: Objection, Your Honor, it's argumentative.
THE COURT: No, you may answer.
A. That was Dr. Seevers' opinion, and Dr. Seevers
like everybody else
is entitled to his opinion.
Q. I understand that. I'm asking you your opinion,
sir. Did you think
they were all prima donnas in all of those Surgeon General's reports
during
the sixties, the seventies, the eighties, and into the nineties? Did
you?
A. I had no reason to make any judgment about that.
Q. You had no reason to call any of them prima donnas;
did you, sir?
A. No.
Q. And in fact Surgeon General report after Surgeon
General report
after Surgeon General report found that smoking causes diseases; didn't
they?
A. If we come back to the definition of the word
"cause."
Q. Yes. The scientific definition of cause that
we discussed earlier
today, you and I. They found it time and time and time again; didn't
they,
sir?
A. No, sir. We still have the -- the dichotomy between
"cause" in the
broad, general sense and "cause" in the specific sense.
Q. I'm talking cause, sir, as found by these scientists
by using
scientific methodology of looking at experiments, looking at associations,
looking at coherency, looking at strength of association, all of those
scientific methodologies, they found it time after time; didn't they?
A. No, sir. We still have the -- the difference
of definition of
"cause." And I accept the Surgeon General's use of the term "cause"
and I
think it's appropriate because he was attempting to educate people
about
risk factors.
*8 Q. Sir, he used the word "cause" based on scientific
methodology
that you and I discussed this morning. Do we have to go through that
again?
MR. WEBER: Object to the commentary, Your Honor.
Q. Do you want to go through that again?
A. No, sir, I don't want to, but I'd be glad to
if you want.
Q. All right. Well then let's do it again.
The temporal association, the consistency of the
association, the
strength of the association, the coherence, the specificity, all of
those
factors, the epidemiology, the toxicology test, all of those that are
taken
together by scientists to determine whether there's cause and effect,
that's what was done in the Surgeon General's report; correct?
MR. WEBER: Objection, Your Honor, it's asked and
answered and
argumentative.
THE COURT: It's not argumentative. You can answer
it.
Q. Isn't that correct, sir?
A. Yes, sir, all of that's correct. But --
Q. And that --
A. -- you still have not settled the issue of "cause."
And I'd be happy
to explain that again if you want me to.
Q. No, because you don't want to accept "cause"
because you want it to
be according to the Henle Koch postulates; isn't that right?
A. No, sir, not exactly. What I want to do is to
be scientifically
accurate. And we know that 93 percent of smokers never get any lung
disease. We also know that smokers are more prone to have lung cancer
than
are non-smokers. So, you know, the evidence is -- is out there, but
it's
not conclusive.
Q. Doctor, you want "cause" based on Henle Koch
postulates. That's what
you want. You want universality; correct?
MR. WEBER: Objection, Your Honor, it's just asked
and answered.
THE COURT: Well that was a different question, universality.
Q. Isn't that right, sir?
A. No, sir.
Q. You accept cause of infectious mononucleosis
even though you know
there's all kinds of other causes for it; isn't that right? Or
Epstein-Barr. You accept that; don't you?
A. Well I don't want to argue with you, but I think
we've answered this
question before, and I -- my only comment is that we've got to accept
the
term "cause" in the broadest sense.
Q. Sir, with regard to infectious mononucleosis,
you accept that the
Epstein-Barr causes it; don't you?
A. Among other things.
MR. WEBER: Objection, Your Honor, asked and answered.
THE COURT: It's been asked and answered.
Q. You don't differentiate "cause" with regard to
infectious
mononucleosis; do you?
A. There are many causes.
Q. Do you -- do you differentiate --
Is that scientific cause, Epstein-Barr?
A. I don't understand the question.
Q. Question is very simple: From a scientific standpoint,
does
Epstein-Barr cause infectious mononucleosis?
MR. WEBER: Objection, Your Honor, asked and answered.
THE COURT: No, this is a new question.
A. It might.
Q. It might?
A. It might in a given individual.
Q. Didn't you say this morning and last week that
it did cause
infectious mononucleosis?
*9 A. It can.
Q. And other things can cause it, too; correct?
A. Yes.
Q. And cigarette smoking can cause lung cancer in
individuals; can't
it?
A. Again we come back to the definition of "cause."
Q. Same thing as Epstein-Barr and infectious mononucleosis?
A. No, sir, I don't think so. They're apples and
oranges and there's no
-- there's no way to compare the two.
Q. Do you know what -- let me strike that.
You said earlier you don't even know how many other
causes for
infectious mononucleosis there is.
A. I don't think anybody does.
Q. But didn't you say that?
A. Yes.
Q. But yet you still say that Epstein-Barr causes
infectious
mononucleosis; correct?
A. Yes.
Q. Okay. Now let's deal with lung cancer. In the
same fashion, wouldn't
you agree that cigarette smoking causes lung cancer?
A. I accept the Surgeon General's definition.
Q. Thank you.
Now can you direct your attention back to 11028
then, which would be
the first exhibit in book one. I'm sorry, in book two.
A. I have that.
Q. Now you recall before we broke this morning we
were talking about
direct and indirect --
A. Yes.
Q. -- cause as articulated in this memo between
the people who had been
interviewed by these individuals who came over from England. Do you
remember that?
A. Yes.
Q. Okay. And sir, can you direct your attention,
then, to the page
eight of that memorandum.
A. Yes.
Q. Now do you remember I asked you whether or not
it wasn't true that
in this memorandum it was being reported that TIRC said there was indirect
causation, but they agreed there was causation? Do you recall that?
A. I recall the questions, yes.
Q. Okay. Now can you direct your attention to the
bottom where they
state their conclusions. Number one, "Although there remains some doubt
as
to the proportion of the total lung cancer mortality which can fairly
be
attributed to smoking, scientific opinion in the U.S.A. does not now
seriously doubt that the -- that the statistical correlation is real
and
reflects a cause and effect relationship." Do you see that?
A. I see that statement.
Q. And that's six years before the Surgeon General
report; correct?
A. Yes.
Q. And then they go -- they go on with the second
conclusion, "There
remains an area for debate as to what is meant by 'causation.' Opinion
differs as to whether or not the cigarette smoke is likely to exert
its
effect by direct action on the lung. An indirect mechanism of causation
is
thought by some to be more likely." Do you see that?
A. Yes.
Q. Now sir, isn't it true that it was the TIRC,
the forerunner of the
CTR, that thought it was the indirect method of causation that was
more
likely than the direct method, as reported in this memorandum?
A. Well this memorandum was written by people that
I didn't know, and I
don't know what their qualifications are nor do I know whether they
are
accurately reflecting conversations that they had. So there are many
if's
here.
*10 I think to get a sense of what the Scientific
Advisory Board
thought at that time, some 40 years ago, it would be better to refer
to the
CTR documents themselves.
Q. Sir, I'm asking you what's reported here.
A. I -- I have --
Q. Is what I said --
A. I have acknowledged that that is reported there.
Q. Is what I said --
A. There's no argument.
Q. Is what I said accurate, then, that the TIRC
was one who thought the
method of causation was indirect as opposed to direct?
A. No, sir, that's not accurate. What's accurate
is what's written
here. What the -- what the Scientific Advisory Board actually thought
and
felt is more accurately portrayed in their own notes and minutes.
Q. Sir, is it reported in this memorandum that the
TIRC in '58 believed
in the indirect method of causation? Is that's what -- is that is what
is
reported?
A. That is what is reported.
Q. Thank you.
Now when you went to the Scientific Advisory Board
minutes, do you know
who wrote those?
A. Well I --
Yes, I know -- I've reviewed some of the minutes
of prior meetings of
the Scientific Advisory Board.
Q. That's not what I asked. The ones that Mr. Weber
showed you, do you
know who wrote those?
A. Who wrote them?
Q. Yes.
A. Members of the staff of the CTR.
Q. And do you know if they were reporting the indirect
method of
causation?
A. I think they -- the minutes speak for themselves.
Q. Now if you look at Exhibit 11028 and you go over
to page seven, --
A. Yes.
Q. -- and the first full paragraph starts with the
word "The group...."
Do you see that there, after that long continuation paragraph on page
six?
A. Yes.
Q. "The group at the National Cancer Institute despite
their lack of
conviction of a direct causal relationship nevertheless advised that
the
tobacco industry must concern itself permanently with the problem of
the
biological effects of smoking." Remember, we talked about that this
morning?
A. Yes.
Q. Then it goes on to talk about whether or not
that type of biological
research was being conducted in the United States by the industry;
correct?
A. Yes.
Q. And here's what's reported: "Finally our attention
was drawn to some
of the very real policy and public relations problems which might arise
if
the industry was seen to be engaged in biological testing. In the U.S.A.
medical opinion on the likely role of smoking in the causation of lung"
--
"Causation" there isn't in quotes; is it?
A. No.
Q. Do you know if they're talking about direct or
indirect causation?
A. I don't know.
Q. Or do you know if they're talking about both?
A. I don't know.
Q. Okay. "In the U.S.A. medical opinion on the likely
role of smoking
in the causation of lung cancer has not become consolidated to anything
like the extent to which it has in the U.K. and TIRC is very much concerned
not to encourage any such consolidation or to do anything which might
further reduce its degree of freedom to criticize and comment. For
this
reason alone it is improbable that TIRC would engage overtly in biological
research with tobacco smoke." Do you see that?
*11 A. I see that.
Q. Now, do you know what position the industry was
taking with regard
to causation in 1958?
A. No.
Q. The industry was saying there was no causation;
weren't they?
A. Was doing what?
Q. The industry was saying there was no causation;
were they not?
A. I don't know that.
Q. Well you know they're doing it even today; don't
you?
A. You asked me what position the industry was taking,
and I don't -- I
simply don't know.
Q. Well do you think they were admitting causation
back in '58 and
they're denying it today?
A. I think the industry, like the rest of us, has
accepted the -- the
statistical relationship and the risk factors involved, but there --
we
still have that question of scientific definition of "cause."
Q. That's not what I asked you, sir.
Were they admitting causation back in 1958 and denying
it today?
A. I don't know.
Q. And you don't know if they are denying or admitting
causation today;
is that your testimony?
A. I don't know, because we have a difference of
opinion about the
definition.
Q. Do you know if CTR today, right today, has admitted
causation?
A. We don't admit or deny anything. We're trying
to find scientific
answers.
Q. Now can you direct --
By the way, I believe you said on direct examination
that CTR never
avoided any type of research and nobody ever suggested that; correct?
A. That's correct.
Q. It goes all the way back to 1954; correct?
A. I believe it does. But clearly I was not there
in 1954.
Q. Direct your attention to Exhibit 10166.
A. Excuse me. The number again, please.
Q. 10166. It's in volume one.
A. I have that.
Q. It's a memorandum dated March 31, 1980 to Dr.
Alex Spears from Dr.
Seligman at Philip Morris, and it's on Philip Morris letterhead; correct?
A. It is a letter on Philip Morris letterhead, not
a memorandum.
Q. Okay.
MR. CIRESI: We'd offer Exhibit 10166.
MR. WEBER: No objection, Your Honor.
THE COURT: Court will receive 10166.
BY MR. CIRESI:
Q. Now sir, do you see that's a letter dated March
31, 1980 from Dr.
Seligman, vice-president, research and development, -- that's in the
upper
left-hand corner -- and it's to Dr. Alex Spears of the Lorillard Company.
Correct?
A. Correct.
Q. And there's carbon copies to Mr. Bowling and
Dr. Osdene. Do you see
that down at the bottom?
A. Yes.
Q. Do you know who Mr. Bowling is?
A. Yes. Was.
Q. Who was he?
A. He was the vice-president of Philip Morris.
Q. Okay. And did you know him personally?
A. Yes.
Q. Did you ever talk to him about smoking causing
lung cancer?
A. No.
Q. Did you ever talk to him about trying to avoid
certain type of
research?
A. No.
Q. "Dear Alex:
"Mr. J. C. Bowling of our New York office asked
that I send you our
recommendations for industry research which we were -- which we prepared
last year. To that end, you will find attached a list entitled, 'Potential
Long-Term Scientific Studies' which Dr. Osdene and I generated early
last
year. Additionally, I have added -- I have added a list of three subjects
which I feel should be avoided.
*12 "If you have any questions, please let me know."
Do you see that?
A. I do.
Q. And can you direct your attention to the third
page, which is
"SUBJECTS TO BE AVOIDED."
Number one, "Developing new tests for carcinogenicity."
Number two, "Attempt to relate human disease to
smoking."
Number three, "Conduct experiments which require
large doses of
carcinogen to show additive effect of smoking." See that?
A. I do.
Q. Do you know if this was the subjects which were
to be avoided by CTR
at that time?
A. This is a letter from an executive of one tobacco
company to an
executive of another. Had no impact whatsoever on what our Scientific
Advisory Board did.
Q. That's not what I asked you.
Do you know if this was a letter concerning subject
matters that should
be avoided by the CTR?
A. I know that this was a letter. This is not in
the CTR files, had --
had no relationship to CTR activities.
Q. Do you know if it related to CTR activities or
not? That's all I'm
asking.
A. I know that it did not.
Q. How do you know that it did not relate to CTR
activities in 1980? Do
you have a letter you can provide us to that effect?
A. Well I think it speaks for itself. This is a
letter from Dr.
Seligman to Dr. Spears. I -- I have no idea of the origin of this document,
but it certainly was not a part of CTR, nor was any of this enunciated
to
CTR, nor would the Scientific Advisory Board have paid any attention
to it.
Q. You weren't there in 1980; were you?
A. No.
Q. So you don't know if this was a subject matter
discussion at CTR; do
you, sir? You yourself.
A. I know that there is -- is no reflection that
any of these topics
were ever avoided by the Scientific Advisory Board.
Q. Maybe you didn't hear my question.
You don't know if this letter related to subjects
that were going to be
avoided by the CTR. You don't know that; do you?
A. I don't know it by personal experience, but I
--
Q. Thank you.
A. -- know from review of the documents that none
of this had any
impact on the Scientific Advisory Board of the CTR.
Q. Doctor, you can't tell us the protocol for one
single study of the
CTR. Not one.
MR. WEBER: Objection, Your Honor, move to strike.
Q. Can you?
MR. WEBER: It's argumentative and been asked and
answered.
THE COURT: It has been asked and answered.
Q. Sir, you don't know what subjects were avoided
or not in 1980 based
on your own personal experience; do you?
A. Yes.
Q. By your own personal experience?
A. By my own personal review of the activities of
the Scientific
Advisory Board and the research that was supported by CTR.
Q. Can you then provide us with the protocols for
one study conducted
by a grantee of the CTR in detail that related to smoking and health?
Can
you provide us with that protocol?
A. Certainly. I will be glad to provide all of the
research protocols
for all of the studies that have been accomplished by CTR.
*13 Q. Can you testify to one here today?
A. I -- I cannot testify to the protocol because
that's a very complex
protocol. Scientifically it means the outline of a scientific methodology.
It will usually run to some four or five pages.
Q. And --
A. And I can't quote that to you.
Q. And you have never conducted a survey to see
if the investigators
themselves felt that their research related to smoking and health.
You've
never done that; have you?
MR. WEBER: Objection, Your Honor, it's asked and
answered.
MR. CIRESI: This question was not asked.
THE COURT: No, I think it's a little different question.
Q. Sir, you have never conducted a survey to see
if the investigators
themselves felt that their research which they got money for from CTR
related to smoking and health; have you?
A. No. And I'll be glad to tell you the reasons
that we haven't if you
want.
Q. Mr. Weber can ask you those if he feels those
are relevant. All
right?
Now you do know that there has been published in
the medical literature
articles relating to what the Scientific Advisory Board feels whether
their
research was related to smoking and health; don't you?
MR. WEBER: Let me object, Your Honor. If he's going
to cross about an
article, I think he needs to establish under the Rules of Evidence
that
it's authoritative and reliable.
MR. CIRESI: I'm just asking him if he knows, Your
Honor.
THE COURT: Well does it relate to a particular article,
counsel?
BY MR. CIRESI:
Q. Sir, are you aware of an article by Dr. Warner?
It's on --
A. Yes.
Q. Okay. Was it published in the medical literature?
A. I think so.
Q. All right. And did that apply to whether or not
members of the
Scientific Advisory Board felt that their research related to smoking
and
health?
MR. WEBER: Same objection, Your Honor. He hasn't
established it is a
learned treatise or authoritative. He didn't ask that.
THE COURT: Well he says he's familiar with it, so
I guess he can answer
the question.
Q. Sir, can you answer the question?
A. What is your last question?
MR. CIRESI: May I have the question back, please,
Mr. Stirewalt.
(Record read by the court
reporter.)
A. There's some confusion there. Scientific Advisory
Board was not
doing research, Scientific Advisory Board was evaluating research projects,
so their research is not at issue here as to whether it was related
to
smoking or not.
Q. Did these Scientific Advisory Board members relate
whether or not
the work of the CTR was related to smoking or health, do you know?
If you
don't know, just tell us that.
A. I don't know.
Q. All right. Now the CTR isn't funding anything
today; is it?
A. Oh, yes.
Q. It is.
A. Yes.
Q. Still funding projects?
A. We're still funding the obligations to which
we committed prior to
last June.
Q. Oh, prior to last June. But you're not -- you're
no longer funding
programs on a going-forward basis; are you?
A. We are not funding any new grants pending the
outcome of the tobacco
legislation.
*14 Q. And that's because the CTR will be dissolved
under the pending
legislation; correct?
A. We don't know that.
Q. That's what's being proposed; correct?
A. It is a --
It was a proposal of the attorneys general.
Q. Now sir -- and -- strike that.
And the industry agreed to it; didn't it?
A. Yes.
Q. Now the Journal of the American Medical Association
is a peer-review
journal?
A. Yes.
Q. It's a premier journal of the American Medical
Association?
A. Yes.
Q. And it's reported on the CTR and its research;
hasn't it?
A. Yes.
Q. You've read it; haven't you?
A. Yes.
Q. And it was highly critical; wasn't it, sir?
A. It was highly biased.
Q. Well doctor, I'm -- I'm really not here to argue
with you whether
it's biased or not. I just asked you whether it was highly critical.
MR. WEBER: Let me object to the commentary, Your
Honor.
THE COURT: Well it certainly was a non-responsive
answer to the
question, so please try and respond to the question.
MR. WEBER: Your Honor, may I enter another objection
before further
questions are asked with respect to this editorial, as to whether the
witness considers it authoritative or a learned document of the type
under
the rule?
THE COURT: With regard to the American Medical Association?
MR. WEBER: With regard to the article that he's
about -- if -- if in
fact he's going to ask specifics about the article, yes, Your Honor.
THE COURT: Well let's wait for the question.
BY MR. CIRESI:
Q. Doctor, may I have an answer to my last question?
It was highly
critical of the C --
A. Yes.
Q. Thank you.
Did you write a response to the comments in this
peer-reviewed journal
concerning the CTR?
A. No.
Q. Did anybody direct you to do so?
A. No.
Q. Did anyone on behalf of the industry write a
response to the peer
reviewed article in the JAMA -- in the JAMA journal?
A. Not to my knowledge.
Q. And JAMA is a peer-reviewed journal; correct?
A. Yes.
Q. It's authoritative; correct?
A. In some instances.
Q. It's reliable; correct?
A. In most instances.
MR. CIRESI: Your Honor, we'd offer Exhibit 18986.
May I approach, Your
Honor?
MR. WEBER: Your Honor, could we have a side-bar
with respect to this?
(Side-bar discussion as
follows:)
(Side-bar discussion concluded.)
BY MR. CIRESI:
Q. Now doctor, are you aware whether or not the
American Medical
Association has taken a position that smoking causes lung cancer?
A. They did.
Q. And they have; correct?
A. Yes.
Q. And has the American Medical Association ever
been critical of CTR?
A. Yes.
Q. Has it been critical of its research?
A. Not of the research, of the source of funding.
Q. Is that the only thing you think the American
Medical Association
has been critical of with regard to CTR, just the source of the funding
and
not its research?
A. I don't know that they've criticized any specific
research, no.
*15 Q. You just don't know one way or the other;
is that what you're
saying?
A. I don't know that they have, no.
Q. So you don't know one way or the other whether
they have or haven't;
is that a fair statement?
A. That's fair.
Q. Now sir, having in mind the fact that you've
never had a specific
subject-matter discussion with any member of the CTR's Scientific Advisory
Board as to whether smoking causes cancer, you don't know what their
research shows; do you?
A. Again, the Scientific Advisory Board, currently
some 15 individuals,
does not do research into smoking and health. They evaluate the proposals,
the applications that we receive requesting funding of independent
research.
Q. Well let me take that answer and see if I can
answer you -- ask you
a question in a different way.
In light of the fact that you've never discussed
the specific subject
matter of whether smoking causes cancer, it would be fair to state
that
when you've reviewed these applications for money from investigators
with
the Scientific Advisory Board, you've never discussed whether any of
those
studies dealt with whether smoking causes cancer; correct?
A. No. We've discussed the issues of causation in
both the scientific
and the lay sense as we've discussed here, so those discussions have
been
open and frank, and I think there is a general understanding among
the
members of the Scientific Advisory Board regarding those issues.
Q. Do you recall giving your testimony last week,
page 4576:
"Question: That's not what I asked you. That specific
subject matter,
smoking causing cancer, you've never had a specific discussion with
any
member of the board in 11 years; correct?
"MR. WEBER: Same objection.
"THE COURT: You may answer.
"The answer is no. We -- we haven't addressed that
specific point."
Now did you give those answers to those questions?
A. I give the same answer. We haven't -- we have
never raised a
question, "Does smoking cause cancer?" We've talked about causation,
we've
talked about risk factors, we've had in-depth discussions about various
aspects of the problem.
Q. Sir --
A. But I've never asked the specific question that
-- that you posed to
me.
Q. So you never asked that specific question; correct?
A. No, sir.
Q. And in looking at the funding for all the projects,
you've never
asked the specific question of any of the Scientific Advisory Board
members, when looking at applications, will this show whether smoking
causes lung cancer. You've never had any.
A. No.
Q. And that's in the entire 11 years; correct?
A. Yes.
Q. Now did any of the executives of any of the companies
in the last 11
years ever ask you that specific question, "Have you folks addressed
the
specific issue does smoking cause cancer?" Have they ever asked you
that?
MR. WEBER: Objection, Your Honor, asked and answered.
THE COURT: It's been asked and answered.
MR. CIRESI: I have no further questions. Thank you,
doctor.
*16 MR. WEBER: Just a very few questions, Dr. Glenn.
BY MR. WEBER:
Q. With respect to the issue of animal inhalation
experiments, do you
remember Mr. Ciresi asking you some questions about that?
A. Yes, sir.
Q. And whether or not lung cancers had been produced
in animal
inhalation experiments?
A. Yes, sir.
Q. Do you know what the position of the United States
Surgeon General
is with respect to the issue of whether animal inhalation experiments
have
produced significant numbers of lung cancers in animals?
A. I do.
Q. What is that position?
A. The position of the Surgeon General is that lung
cancer has not been
produced in animals by inhalation studies.
Q. And with respect to page 218 of the 1982 Surgeon
General's report,
is this language that which you're referring to: "Attempts to induce
significant numbers of bronchogenic carcinoma in laboratory animals
were
negative in spite of major efforts with several species and strains?"
A. Yes, sir.
Q. By the way, Mr. Ciresi also asked you some questions
about the 1964
Surgeon General's report.
A. Yes.
Q. At the beginning of the 1964 Surgeon General's
report, did the
Surgeon General's Advisory Committee include the Tobacco Industry Research
Committee as one of the persons and institutions that's thanked for
their
cooperation?
A. Yes.
Q. Did it include Dr. Little?
A. Yes.
Q. And did it include Dr. Hockett as well?
A. Yes.
Q. On this issue that Mr. Ciresi has asked you about,
about whether or
not there ought to be a survey of the grantees as to what their viewpoints
are with respect to causation and what definition of "causation" they
use,
do you remember those questions?
A. Yes.
Q. Do you think conducting such a survey would be
a good or a bad idea?
A. Oh, I think it would be a disastrous idea. In
the first place, the
grantees might take the position that we were asking their opinion
about
smoking and diseases as a basis for whether or not we would award funds,
and I would be terribly -- I think people would be terribly critical
of a
survey in that respect. So I think to maintain independence with the
investigator, we'd have to avoid such a survey.
Q. Would such a survey provide scientific information?
A. No. A survey of that type would depend on how
-- how the individual
defined the word "cause," so it would be statistically insignificant
and
scientifically inaccurate.
Q. Now Mr. Ciresi also asked you some questions
about whether or not
you'd ever engaged in any discussions regarding taking carcinogens
out of
cigarettes. Do you remember that?
A. Yes.
Q. Is CTR allowed to get into product development
issues?
A. No, sir. And we have avoided it specifically.
Q. Now he also read you a portion -- and I might
be able to put this on
the Elmo if you don't remember it -- where he talked about how TIRC,
at
least according to this 1958 memorandum, was reluctant to do biological
research of tobacco smoke. Do you remember that?
*17 A. I do.
Q. Has TIRC or CTR done biological research with
tobacco smoke since
1958?
A. Yes, sir. In the early days of TIRC a lot of
biologic studies were
accomplished, and as I've explained to the jury before, the evolution
of --
of science in general has dictated that we go down more and more to
the
molecular, cellular, chemical level. But in the early days, you know,
we
supported a great deal of so-called biological research, one major
inhalation program -- several -- several major inhalation programs.
So
biological research was certainly prominent in the early days.
MR. WEBER: Thank you very much, Dr. Glenn. That's
all I have.
MR. CIRESI: Just two -- about three questions. Deals
with the Surgeon
General report. That's -- that's all really I have.
THE COURT: All right.
MR. CIRESI: I'll let them go. That's fine.
THE COURT: Then, doctor, you may step down, but
you are subject to
recall.
THE WITNESS: Thank you, sir.
THE COURT: We'll take a short recess.
THE CLERK: Court stands in recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
MR. GARNICK: Your Honor, may we have a brief side
bar before we get
started with the next witness?
(Side-bar discussion as
follows:)
(Side-bar conversation concluded.)
THE COURT: Good afternoon.
THE WITNESS: Good afternoon.
THE COURT: Counsel, all set? Go ahead.
MR. HAMLIN: Your Honor, at this time plaintiffs
call Professor Scott
Zeger.
(Witness sworn.)
THE CLERK: Will you please state your name and spell
the last name for
the record.
THE WITNESS: Scott Louis Zeger, Z-e-g-e-r.
THE CLERK: Be seated, please.
SCOTT L. ZEGER called as a witness, being first
duly sworn, was
examined and testified as follows:
BY MR. HAMLIN:
Q. Good afternoon, Professor Zeger.
A. Good afternoon.
Q. My name is Tom Hamlin. I'm one of the attorneys
for the plaintiffs
state of Minnesota and Blue Cross Blue Shield in this case.
Dr. Zeger, what is your current position?
A. I'm professor and chairman of the department
of biostatistics at
Johns Hopkins University School of Public Health.
Q. Can you briefly describe for the court and the
jury what
biostatistics is.
A. Yes. There's two parts to it, bio and statistics,
so let me start
with statistics. Now statistics is a set of principles and methods
for
using quantitative information; that is, numbers, to figure out quantities
or -- or -- or things of interest, to calculate quantities that we're
interested in about a population of people.
And bio refers to the application of statistical
methods to public
health or medicine.
Q. Dr. Zeger, what are your duties and responsibilities
as chair of the
department of biostatistics at Johns Hopkins?
A. Well as chairman of the department of biostatistics
I'm a faculty
member, like the rest of my department, and as a faculty member I conduct
research on public health problems, I conduct research on statistical
methods, and I teach students, medical and public health students as
well
as Ph.D. students in my own department who are training to also become
I
biostatisticians, and as chair of the department I'm the administrative
director of my department and am responsible for the running of the
department, for hiring new faculty, for the academic programs that
we
offer, and for managing the business of the department as well.
*18 Q. How many faculty members are in your department?
A. I believe we currently have 13 tenure-track faculty
and three
others.
Q. Can you tell us the range of their professional
training and
expertise?
A. Yes. Nearly all are Ph.D. trained, they're mostly
trained in
biostatistics, we have one faculty member who is also a physician,
and
their expertise is in the application of statistical methods to public
health problems.
Q. Doctor, do you conduct your own research?
A. I do.
Q. And can you tell us the kinds of research that
you yourself conduct.
A. Well there's two kinds of research that I do
as a professor of
biostatistics. In the -- in the first kind I work with -- I collaborate
with the public health scientists, with physicians or medical researchers,
in order to address public health questions, to address the solution
of
public health problems, and in those collaborations I represent the
quantitative expertise and my medical colleagues represent the medical
or
health expertise.
And then I do another kind of research as well.
In the course of my
public health collaborations we sometimes find opportunities to develop
new
statistical methods, new tools that could be used in the public health
problem we're working on, but also could be used by other public health
problems -- by other researchers doing other public health -- addressing
other public health problems.
Q. What are some of the courses that you teach?
A. I teach two kinds of courses. I teach courses
to physicians and
other health scientists, and typically those courses are teaching these
health scientists how to use statistical methods in their professional
research or practice, and then I teach courses that are to graduate
students training to become biostatisticians, and those courses tend
to be
more mathematically oriented, more statistical in nature.
Q. Can you identify some of the subject matters
of those courses?
A. Yes. The courses that I teach to the physicians
and other health
scientists -- I'm teaching one now to the faculty in the medical school
of
Johns Hopkins entitled "Quantitative Methods for Clinical Research,"
so
it's training the -- many of the students who are on the faculty already
how to be better researchers. Or I would teach an introduction to
biostatistics, which would be a course for people who are -- for --
for
medical scientists or public health scientists who are learning how
to use
statistical methods in their work. And then these other courses that
are to
our graduate students tend to be more technical. I teach there how
to do
statistical modeling. I teach --
One of them is called "Generalized Linear Models"
and one is called
"Analysis of Longitudinal Data." All are about statistical models as
applied to biological or public health research.
Q. How long have you been chair of the department?
A. I've been chair for two years.
Q. Doctor, I now want to go over your education.
Where did you obtain
your undergraduate degree?
*19 A. At the University of Pennsylvania, which
is in Philadelphia.
Q. And what was your undergraduate degree in?
A. My degree was in biology.
Q. When did you obtain that?
A. In 1974.
Q. And did you pursue graduate studies?
A. I did.
Q. Where?
A. At --
I first earned a master's degree in the evening
in mathematics at
Drexel University in Philadelphia. I was doing that part time while
I was
working at an institute called the Academy of Natural Sciences in
Philadelphia. And then I went back and earned a Ph.D. in statistics
from
Princeton University.
Q. When was that?
A. I earned the Ph.D. in 1982.
Q. And did you write a thesis?
A. Yes, I did.
Q. What was the subject matter of the thesis?
A. The thesis was addressing -- if you remember
back to 1982, there was
concern about whether spray can aerosols were destroying the ozone
layer,
and at the time we didn't have sattelite information, and so the thesis
was
about looking at the ground measurement systems we had for looking
at
stratospheric ozone, or the ozone in the -- high up in the atmosphere,
and
seeing whether there was evidence of -- of -- of ozone being diminished
by
these spray cans. And so my Ph.D. thesis was using that data and developing
statistical models to address the question of whether the ozone was
being
depleted or not.
Q. After you obtained your Ph.D., what did you do?
A. I took a position as assistant professor at Johns
Hopkins University
in the department of biostatistics, the department I'm currently in.
Q. Was that in 1982?
A. Yes.
Q. What were your duties and responsibilities as
an assistant
professor?
A. Well, from the beginning I was responsible for
the three activities
which I described, for collaborating with health scientists in public
health research, with doing research on developing better statistical
tools
to be used in that research, and in doing education of both health
professionals and statistical graduate students.
Q. How long were you an assistant professor?
A. I believe it was four years.
Q. And what happened after those four years?
A. I was promoted to a rank called associate professor,
which is the
next rank in the ladder.
Q. And did your duties and responsibilities change?
A. It was the same general area of responsibility.
I -- I -- I began to
take on some additional responsibilities for academic committees and
developing curricula, things like that, but the basic areas were the
same.
Q. How long were you an associate professor?
A. I believe it was five years.
Q. And then what happened?
A. And then in 1991 I was promoted to a professor
in the department of
biostatistics.
Q. Did your duties and responsibilities then change?
A. Same areas, collaboration with health scientists,
statistical
research and teaching, but again the -- the responsibilities increased
as I
became older and in the department.
Q. Did you take on any other positions at Johns
Hopkins in 1991?
*20 A. Yes. We -- we had a new dean at Johns Hopkins
in 1991, and he
asked me to be the academic dean for the school, which I did for a
period
of five years.
Q. And what were your duties and responsibilities
as academic dean?
A. I was responsible for all of the academic programs
for the faculty,
students, and all of the interactions that they'd had in our teaching
programs at the Johns Hopkins School of Public Health. It's a school
of
about 250 faculty plus about 1800 students, and we run quite -- several
graduate programs which I was responsible for.
Q. How long were you academic dean?
A. For five years.
Q. And then what happened?
A. Then I was given the opportunity to be the chair
of the department
of biostatistics, and I -- I took that position and have been there
since.
Q. Doctor, have you published in peer-reviewed journals?
A. Yes, I have.
Q. Can you just describe for us briefly what a peer-reviewed
journal
is.
A. Yes. A peer-reviewed journal is where you submit
a paper for
publication and the -- there is an editorial process where the editor
sends
out the paper to your peers, people who have expertise in the topic
about
which you are writing, and they review the papers and make a recommendation
back to the editor as to whether the paper merits publication or not.
Q. What types of articles have you published in
peer-reviewed journals?
A. Well like my research, I -- I publish two kinds
of articles. In the
first case, I and a collaborator with medical scientists or public
health
scientists, and we work on a problem together, it's usually a public
health
problem, they bring the medical expertise or the health expertise and
I
bring the quantitative expertise, and together we would write an article
about the health issue which is being addressed. So that's one kind
of
article that I would be a co-author on with other investigators as
well.
And then the second kind of research I do is what
I would call
biostatistical research. It's in trying to new tools, new techniques,
new
statistical models that could be used in public health research or
in
research by others as well.
Q. Have you written about statistical models to
address public health
questions?
A. Yes.
Q. And I have your CV here and I'd like to ask you
about a couple of
articles. The first one is entitled "Longitudinal Data Analysis for
Discrete and Continuous Outcomes." That appeared in the journal called
Biometrics; is that right?
A. Yes.
Q. That was in 1986?
A. That's correct.
Q. And you were one of the authors?
A. Yes. I was an author with my colleague, Dr. Kung-Yee
Liang.
Q. What was the subject matter of that article?
A. This was a -- an example of one of these papers
where we were trying
to develop new techniques for analyzing data, and the -- the need for
the
new techniques arose out of some of the collaborative work I had been
doing
in public health, and in this particular paper we were developing
statistical models that could be applied to data collected by following
people through time. So these studies are called "longitudinal studies,"
if
you follow people forward in time. And the methods that were developed
in
that paper were to address data of that kind.
*21 Q. And did that paper address regression analysis?
A. Yes, the method -- the methods that were developed
in that paper are
sometimes referred to as regression analysis, which just means that
you
have a health outcome that you're interested in, and you're interested
in
how it relates to a variable, like what some people call a risk factor,
and
the studying of the relationship is sometimes called regression analysis.
Q. Did that paper receive any awards?
A. It did.
Q. What -- what award did it receive?
A. It was named by the International Biometrics
Society and the
American Statistical Association as the best paper in biometry, in
biostatistics of that -- of that year.
Q. Now you've used the term "Biometrics." What does
that mean?
A. Yes. Biometrics was the name of the journal,
and it's sort of an
old- fashioned word for biostatistics. It -- it describes the use of
statistical reasoning and statistical methods in health research or
biological research, more generally.
Q. Is that paper still recognized as an important
contribution?
A. Yes, I believe so.
Q. And why is that?
A. It recently has appeared in a -- a publication
that -- that presents
-- republishes sort of the best papers of the -- of the 1980s, and
that was
one of the papers chosen to appear there.
Q. Now I want to direct your attention to another
paper on your CV.
That one is entitled "Statistical Methods for Monitoring the AIDS
Epidemic." And that was published in the journal Statistics and Medicine;
is that right?
A. I believe so, yes.
Q. What was the --
And you were one of the authors?
A. Yes.
Q. What was the subject matter of that paper?
A. This is another example of a statistical paper,
a paper developing
better tools, that grew out of my work in a study called the Multi-Center
AIDS Cohort Study, or MAX, and it was -- it was work that we did in
order
to understand the -- what HI -- what human immune deficiency virus
was and
how the AIDS epidemic was growing. And in this particular paper we
developed regression methods to describe how fast the AIDS epidemic
was
growing in -- in various subpopulations of people, looking at people
who
contracted AIDS in different ways, from -- from transfusion of blood
if
they were hemophiliacs, or through sexual contacts. And this -- this
paper
laid out a technique for estimating how fast the epidemic was growing
in
these many subgroups.
Q. And did you use statistical modeling?
A. Yes.
Q. Have you also authored a book entitled "Analysis
of Longitudinal
Data?"
A. Yes, I have, with co-authors Peter Diggle and
Kung-Yee Liang.
Q. Was that published in 1994?
A. Yes.
Q. What is the subject matter of that book?
A. As I said before, a longitudinal studies are
studies where we follow
people forward in time, and they are very common in -- in health research,
and this -- this book laid out a set of regression methods for data
of that
sort.
Q. You also serve as an editor of peer-reviewed
journals?
*22 A. Yes, I do.
Q. What journals have you served as an editor for?
A. I served, I think, for 10 or 11 years as associate
editor of the
Journal of the American Statistical Association. And I'm on the --
I'm on
the editorial board of a large publisher of statistical books called
Springer-Verlag. They publish statistics books and mathematics books
and
other scientific books, and I'm on their statistics editorial board.
Q. Do you also serve as a reviewer of papers?
A. I do.
Q. Now what does a reviewer do?
A. Well a reviewer is the person to whom a journal
sends a paper that's
been submitted for publication, and a reviewer is responsible to study
the
paper and to make recommendations to the editor as to whether the paper
should be published or not, and also back to the author of the paper,
you
know, in ways that the paper might be improved, whether or not it's
published.
Q. What journals do you serve as a reviewer for?
A. I review for most of the major statistics and
biostatistics
journals, Biometrics, Journal of the American Statistical Association,
and
Biometrica, Statistics and Medicine, several of them, as well as for
journals that publish about health issues. So they -- they often look
for a
statistical reviewer as well as a health expert to review papers for
the --
from the health literature.
Q. Have you also been a member of review panels
for other departments
of biostatistics?
A. Yes. Yes, I have. Many times a -- a -- a dean
of a school will,
every five or six years, bring in a few outside experts to review their
own
department of biostatistics. And so, for example, I think -- I think
it was
last year, Harvard University had three of us come and spend a couple
of
days studying the work of the department of biostatistics at Harvard
and
then to make recommendations to the dean about, you know, the quality
of
the work and how the work might be improved.
Q. Have you served on review panels for other institutions
in addition
to Harvard?
A. Yes, I have.
Q. Which ones?
A. I think the University of Alabama at Birmingham,
and several --
University of Rochester, North Carolina -- University of North Carolina.
Several others.
Q. Have you also done work as a scientific reviewer
for federal
agencies?
A. Yes. The biggest funder of biomedical research
is the National
Institute of Health, and they have a peer-review system for grants,
and
when a grant is submitted, they empanel experts in the field and the
experts review the submitted grants, all of the submitted grants, and
then
make recommendations about which ones should be funded. And so I served
on
these review committees of other people's grants.
Q. You also served on a review committee for the
Environmental
Protection Agency.
A. Yes. For many years the Environmental Protection
Agency also ran its
own research program, and I was on their scientific review panel.
Q. Doctor, could you list for us your professional
memberships?
A. I'm a member of the International Biometrics
Society, of the
American Statistical Association, of the Institute of -- the International
Statistical Institute, and the Royal Statistical Society of England.
*23 Q. And did you serve as an officer in the International
Biometrics
Society?
A. Yes. I was in 1995 president of the Eastern North
American Region of
the International Biometrics Society.
Q. Are you also a member of the American Public
Health Association?
A. Yes, I am.
Q. Doctor, I'd like -- excuse me.
Professor, I'd like to talk about your awards now.
You -- you mentioned
the award that you received for your paper. Have you received any other
awards?
A. Yes, I have.
Q. And can you tell us about those.
A. I received an award from the American Public
Health Association
called the Spiegelman Award, which was in recognition of the best
biostatistician under the age of 40. I think this was in 1992 or '3
or
something like that.
Q. Professor, are you still eligible for that award?
A. No comment.
Q. And were you also elected a fellow of the American
Statistical
Association?
A. Yes, I was.
Q. When was that?
A. I believe it was last --
Two years ago.
Q. And can you tell us what that means?
A. Well the American Statistical Association I think
elects
approximately one percent of its membership to be what are called fellows,
perhaps gals, but which is a distinction of -- an acknowledgment of
your
contribution to the field of statistics.
Q. And have you received other awards?
A. Yes, I have.
Q. Could you tell us about those.
A. Yes. I recently received an award from Johns
Hopkins University for
contributions to the educational programs of the university, I think
in
recognition of my service as dean.
Q. You also serve as the scientific advisor to private
industry?
A. Yes, I do.
Q. Can you tell us about that.
A. I'm a member of the Scientific Advisory Board
for the Merck Research
Laboratory, which is -- Merck is a large pharmaceutical company, and
so I
am a member of a board of people who review annually their scientific
research programs and make recommendations about, you know, where --
what
are areas they might work in and -- and ways of strengthening their
programs.
Q. Now Dr. Zeger, you -- I'm getting this -- I'll
get this title
straight.
Professor Zeger, you have briefly described for
us biostatistics. Can
you give us a more detailed explanation of what you mean.
A. Yes. Again, the bio part refers to working in
public health, working
on public health problems, and statistics is a field that -- that really
is
a set of ideas or principles as well as a set of methods, tools that
we use
to take quantitative information, numbers, and draw -- draw conclusions
about substantive questions, about health questions. So if I can say
that
again, statistics is taking -- is a set of ideas, a set of methods
and
principles by which we use information, usually numbers, in order to
calculate and study quantities of interest like health effects, for
example.
Q. Can you --
Can you give us an example of a statistical principle?
A. Yes. Actually if I could come to the --
*24 Q. With the court's permission, can Dr. Zeger
please come down and
use the flip chart.
A. Yes. When I say a statistical principle, it's
-- it's a little --
there is -- it's basically a way in which we -- it's a principle by
which
we operate when we use quantitative information, and the one I've just
chosen to illustrate this is what some -- many of you perhaps have
heard
of, which is called the law of averages. And it's just an example of
a
statistical principle.
And to illustrate what the principle is, it's easiest
to do this with a
little experiment. And rather than bringing 20 coins in here and flipping
them in front of you, I flipped them a couple of days ago. I'm just
going
to write on the board the series of heads and tails that I got when
I
flipped them to illustrate this principle.
So the first flip was a tails, or T, and then another
tails, and then a
heads, and then a tails, and then a heads, then a heads, and a heads,
and a
heads, and a tails, and a tails. That was the first 10. And if I just
carry
on quickly, heads, tails, tails, heads, heads, tails, heads, heads,
tails,
heads. I think that's 20. Let me just count. Yes. So it was 20 coin
tosses.
And the principles I'm illustrating is the law of
averages. And what
the law of averages says is that if you're interested in whether this
is a
fair coin or not; that is, of whether about half the time the coin
will
give heads and half the time it will give tails, we can use this quantity
-- this information, the results of this little experiment where we
flipped
a coin 20 times to -- to see what it says about that, whether or not
this
is a fair coin. And if we look, we can count the numbers of heads,
one,
two, three, four, five, six, seven, eight, nine, 10 -- there were 11
heads
out of 20 coin tosses, and so it came up heads 55 percent of the time.
Now if we were interested in knowing the probability
of getting ahead,
you know, 55 percent is a pretty good estimate, and what the law of
averages tells us -- and it's an example of a statistical principle
-- that
if you flip the coin many times, keep flipping lots of times and then
just
count the proportion of heads, the percentage of heads, that the more
times
you toss, the closer the proportion of heads will come to the true
value,
which for a fair coin is 50 percent. So tossing 20 coins, we got the
observed proportion of heads, 55 percent. But the law of averages says
that
if you flip many, many, many times, hundreds of times, that the observed
proportion would get closer and closer to the true value; namely, for
a
fair coin, 50 percent. So that's an example of a statistical principle.
Q. Doctor, can you pick a subgroup and tell us what
that subgroup tells
us about the law of averages and whether or not this is a fair coin.
A. Well I -- I wrote down 20, the results of 20
tosses. I could have
only done, say, three or four, so let me just take the first four,
for
example. And in the first four we got tails, tails, heads, tails. And
if
that's all we had done, we would have had what fraction of heads, what
percentage of heads? Only 25 percent, one out of four or 25 percent.
And
what the law of averages tells us, that if you only have a few tosses,
you
-- you won't necessarily come as close to the true value, the true
proportion of heads, as if you have many, many tosses. So by tossing
more
times, the law of average tells us we get closer to true percentage
of
heads.
*25 So looking at four will give you a less-precise
estimate of the
true probability of heads than looking at 20.
Q. Could you pick another subgroup, perhaps the
four heads.
A. Well the other thing to mention is when talking
about the law of
averages is, you know, when I look at just the first four, I get quite
far
away from the true value. The other thing sometimes we're tempted to
do is
to look along a sequence, and say, oh, look at this, heads, heads,
heads,
heads. We should -- we should say it's a hundred percent chance of
getting
a head. That is to say the law of average tells us if you look at all
of
the information and there's enough information, it will get close to
the
true probability of a head. But if you search purposefully for heads,
okay,
for sequence of heads and then say aha, see, I have four in a row,
that
must mean the probability of a head is a hundred percent. You can get
very
far from what the truth is. Okay?
So the law of averages is just an example of a statistical
principle,
and it's the kind of thing we use in our work every day.
Q. Okay, thank you. Resume your place on the stand.
Now you mentioned that bio was also a part of the
word biostatistics.
Could you tell us more about that, please.
A. Yes. Well bio comes from biology, but these days
the -- because
medical research has become such a large area of research, most
biostatisticians work on public health or medical problems, so there
are
still biostatisticians who work more on biological problems outside
of
medicine or public health, but I work in public health and most
biostatisticians do as well.
Q. Now what do you mean by "public health?"
A. The word "public health" really refers to exactly
what it says, it's
the health of the public. Public health is about how to maximize the
health
of populations of people, and it's a little bit different than medicine.
I
like to think that public health includes medicine as a special case.
Medicine is about individuals and the treatment of their disease; public
health is about the health of the population, which obviously includes
the
health of individuals and treatment -- developing better treatments,
but it
focuses on populations as opposed to just having to worry about one
individual.
Q. Now as a biostatistician, what do you do specifically?
A. Well I do the three things I mentioned earlier,
I collaborate in
addressing public health problems, I -- I do statistical research trying
to
understand the principles and the methods used in public health research,
and I also teach.
Q. Now what do you mean by "collaboration?"
A. Well in order for --
In order to do public health research, you need
teams of individuals
with different sorts of skills, and so I'm often a member of a team
of
individuals that would include a health scientist, like a physician
or a
biochemist or a person who is knowledgeable about human health and
disease,
but -- but what I bring to the collaboration is expertise in quantitative
sciences, in the use of statistics in -- in -- in this sort of research
endeavor. So collaboration, what I mean is there are teams of individuals
who bring different skills, work together to solve a public health
problem.
*26 Q. What if any part of your training assists
you in communicating
with these other health scientists, professor?
A. Well to be an effective biostatistician, you
have to have expertise
in statistics, but you also have to have a working knowledge of public
health or medicine so that you can communicate effectively with the
public
health scientist with whom you're collaborating.
Q. How important is collaboration?
A. I think to make a meaningful contribution to
solving a public health
problem, you need people of different skills, so I would say collaboration
is essential in order to -- to make a contribution to solving a health
issue -- health problem, and certainly it is for a statistician. A
statistician working on a health problem would be lost without a --
a
medical scientist or health scientist who's knowledgeable in that
particular problem.
Q. How does collaboration work generally?
A. Well typically what you would do in a collaborative
project is you
-- the team individuals would come together, you would frame the questions
you're going to address, and you would then, you know, meet regularly
every
week, every third day and -- and -- and -- and discuss progress that's
been
made and what the next step should be. People would take those steps,
and
you would continually meet and work together, and eventually, once
you had
results, would write papers together for the published -- for the
peer-reviewed literature.
Q. Now are there examples of collaboration with
health scientists on
your CV?
A. Yes. As I said, I spend a considerable part of
my time on such
collaborations.
Q. Let me ask you about a couple of articles. One
is entitled "AZT Used
in AIDS for HIV1 Seropositive Homosexual Men, 1987 to 1989," that appeared
in the Journal of AIDS. You were one of the authors of that paper?
A. Yes, yes, that was --
This is an example of a paper where I was collaborating
with a
physician and epidemiologist, Dr. Neil Graham, who at the time was
at Johns
Hopkins University, and with several other physicians and empidemiologists
at institutions across the country. And this was a paper that came
out of a
Multi- Center AIDS Cohort Study which I mentioned previously. That
study
was started by the National Institute of Health in 1983. At the time
we
knew that gay and bisexual men were becoming sick from very rare cancers
and infections, so we knew that their immune system wasn't working
right,
but we didn't know at the time about the virus, the human immune deficiency
virus. That hadn't been discovered yet. And the National Institute
of
Health formed this study in order to try to figure out what was going
on,
why were these men becoming sick, and what were the factors that influenced
who got sick.
And so this particular paper came a little bit later.
It was back -- it
was, I think, in about 1987 or so, 1988, and it was after the first
treatment for AIDS called AZT had been discovered and -- and licensed,
and
this paper was trying to look at who gets AZT and whether it's actually
being used in -- in the population of infected men who were entitled
to get
it, and what the barriers were to their getting AZT to which they were
entitled.
*27 Q. Now what did the health scientist, Dr. Graham,
contribute?
A. Well Dr. -- Dr. Graham is an AIDS specialist,
he treated AIDS
patients and was also trained in epidemiology, and so he -- he identified
what the important question was and -- and also what the important
data
was. And we worked together on using that information, using that data
to
address the question of who gets AZT and why, what are the factors
that
influence who gets it.
Q. What did you contribute, Professor Zeger?
A. Well this -- this was an example of a -- a study
in which we
followed people through time, and so I contributed those methods that
I had
mentioned earlier, statistical methods, modeling techniques for
longitudinal data.
Q. How did the collaboration work between you and
the other health
scientist?
A. Well we would meet -- I think back then we were
meeting several
times a week. We had a programmer who was working with us, and we would
look at the information, make some decisions, make some tables, study
--
study the data, ask, you know, follow-up questions, work further. And
--
and over a period, it must have been six months to a year, we developed
the
-- the study -- the -- the analyses of the Multi-Center AIDS Cohort
Study
data that led to that paper and a few others.
Q. Let me ask you about another paper on your CV.
That one is entitled
"Statistical Models of Air Pollution and Mortality in Philadelphia,"
published in the American Journal of Epidemiology. Could you tell me
whether that's another example of the collaborative effort?
A. Yes. This is again a paper that was asking a
-- addressing a public
health question. The question arose not too long ago when it was noticed
that if you look at daily fluctuations in the numbers of people who
die in
American cities, that if you tend to have a high pollution day, the
next
day you get more deaths than you did if you didn't have a high pollution
day. And this was quite a surprising finding because we've done a lot
of
good work to reduce the pollution levels in American cities, and the
fact
that there's still a potential association between current levels and
mortality was somewhat surprising.
So this was a study that was undertaken, led by
Dr. Jonathan Samet, who
testified here, my colleague from Johns Hopkins University, and --
and I
participated as the biostatistician. There was another biostatistician
who
-- who participated. And we -- we've been working now for about 18
months
on this project to try to understand what it is about the air pollution
that might -- might cause increased mortality.
Q. What is Dr. Samet's background and training?
A. Well Dr. -- in this --
Dr. Samet is an epidemiologist and a physician,
a pulmonary physician,
so he has expertise in the human lung. And this was a study of potential
--
of air pollution as a potential risk factor for -- for the functioning
of
the lung.
Q. And what did Dr. Samet contribute to this study?
A. Well Dr. Samet was the medical expert. Rather
than just looking at
the data, he would help us frame the question from a medical perspective,
so that when we did analysis, we addressed the relevant medical question.
And he and I have collaborated with a third person, as I had indicated.
*28 Q. And what did you contribute?
A. Well again, this was a fairly complicated data
set. There was lots
of information. The particular paper you referred to was data from
Philadelphia. We used Philadelphia because we had about 5,000 consecutive
days of mortality information, and air pollution information, and lots
of
different air pollutants, too, not just one or two, so my contribution
was
to -- was to figure out how to do statistical modeling to address the
question of whether there was an association between air pollution
and
mortality.
Q. How did the collaboration work?
A. Well just like the first example, we -- you know,
we would meet two,
three times a week, we had -- we also had programming assistants, and
we
would take the -- the data, the data that had been available and --
and
work together to try to understand the -- the evidence and the data
about
the association between pollution levels and mortality. But it involved
regular meetings, and it's been going on now for about 18 months. And
that
was one of our early papers from the effort.
Q. Let me ask you about another paper on your CV,
this one is entitled
"Passive Smoking, Air Pollution And Acute Respiratory Symptoms in a
Diary
Study of Student Nurses." Can you tell me whether that's an example
of a
collaborative effort?
A. Yes, it is. It's another example. And in this
case my collaborator
is now a professor at Harvard University School of Public Health, his
name
is Joel Schwartz. At the time I was working with him he was a senior
scientist at the Environmental Protection Agency. And he had this data
set,
this really unique data set where nurses agreed to keep daily records
of
their respiratory symptoms, whether they had a fever, whether they
were
coughing, phlegm, other conditions like that. So you had every day,
filled
out all the forms, of what their respiratory conditions were. And in
addition there was information about their smoking, about their roommate's
smoking, and about the air pollution levels around the nursing school.
And
there was, I think, about 200 nurses who agreed to do this for quite
an
extended period of time, so it was an invaluable source of information
to
try to understand, you know, the roles of smoking, environmental tobacco
smoke and air pollution in -- in causing respiratory symptoms, coughs
and
-- not -- not serious disease, but -- but -- but diminished health.
Q. What did Dr. Schwartz contribute?
A. Well Dr. Schwartz is an air pollution specialist
and had done
numerous studies previously looking at the health effects of air pollution,
and so he -- he was the substantive expert, the pollution health expert.
And I again brought the expertise in quantitative methods.
Q. And did this --
Did the quantitative methods include statistical
models?
A. Yes. So we did statistical modeling of that data
to address the
question I described.
Q. Now we've talked about statistical models generally.
Can -- can you
tell us what a statistical model is?
*29 A. Yes. That word seems to be used for just
about everything. A
statistical model -- let's start with model, because we all know what
we
mean by a model. A model is an approximation to reality. It's -- it's
an
approximation to something. So the simplest example is a model airplane.
It's not -- it's not a real airplane in the sense that I can't get
in a
model airplane and fly back to Baltimore, so it's not a real airplane,
but
it's -- it's an approximation of an airplane. It's built to look like
the
airplane. And it's a -- in -- in many situations it's a tool. If you
think
about how we build airplanes today, how you design and build airplanes
today, in fact I saw a television show where -- where -- where they
described the building of the Boeing 777. They built lots of model
airplanes and actually had done some -- some statistical models as
well,
but lots of model airplanes, physical model airplanes in order to figure
out how the real airplane would fly. So if you wanted to know something
about how air might flow across the wings of an airplane, whether it
would
have very much turbulence or not, it would be a stable airplane or
not, how
you should design the wings so to minimize the turbulence, well you
might
build a model airplane and put it in a wind tunnel and then watch to
see
how the airplane performs. It's not a real airplane, but it's an
approximation to the real airplane, and it's a tool that we use in
studying
the real airplane.
So that's what I mean by a model. It's an approximation
to reality.
It's a tool that we use to study something.
Now what's a statistical model? Well if we follow
this -- this model
airplane a little bit further, suppose we were going to build a real
airplane but we started with a physical model in order to study the
turbulence around the wings. We might be considering lots of different
wing
designs, might be slightly different angles or slightly different shapes.
And what we might do is -- is, in the model airplane, vary the shape
of the
wing a little bit, and for each wing shape actually measure, quantitatively
measure the degree of turbulence, so for all the different wing shapes
we
built models for, we would have a measure of the degree of turbulence.
Then
a statistical model would take those quantitative -- that quantitative
information, the shape, that describes the shape of the wing and describes
how much turbulence there was, and try to look to see how these things
are
associated with one another.
Why would we do that? Because we want to build a
wing for the real
airplane that has a minimum amount of turbulence. So that would be
an
example of a statistical model analogous to the physical model of the
airplane which I described.
Q. You used the term quantitative information. What
-- what do you mean
by that?
A. I basically mean numbers. You know, if you're
trying to measure
turbulence, there -- there -- there's sort of a measuring device which
one
might use -- I'm not expert in this, but -- but I'm -- I'm saying that
what
you'd do is you would measure a number that would characterize the
nature
of the turbulence and -- and then also numbers to represent the shape
of
the wing, and then you'd study using the numbers how the shape of the
wing
was related to the degree of turbulence.
*30 Q. Taking your example, doctor, once the statistician
took these
measurements, what if any assistance would the statistician seek then?
A. Well, you wouldn't make very much progress, I
don't think, unless
the statistician was collaborating with, in this case, an aeronautical
engineer, somebody who knew about wings and turbulence. You wouldn't
make
very much progress if you just worked in a vacuum.
Q. Now have you yourself said that statistical models
for data are
never true?
A. Yes, I --
It's sort of like saying you can't fly in a model
airplane. They're --
they're approximations to reality. They're tools that we use in order
to
address particular questions.
Q. Have you prepared an example of a statistical
model?
A. Yes, I have.
Q. I want to direct your attention now to Trial
Exhibit 30176. And is
that an example of a statistical model?
A. I'm sorry, could you repeat the number again?
Q. Yes, 30176. That's in the book in front of you.
MR. HAMLIN: Your Honor, we have placed your demonstrative
book to your
right.
A. Yes, I have it.
Q. Now is that an example of a statistical model?
A. Yes, it is.
Q. And this was prepared by you?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30176
for illustrative
purposes.
MR. GARNICK: No objection.
MR. HAMLIN: Can we have that on the Elmo, please.
THE COURT: The court will receive 30176 for illustrative
purposes.
BY MR. HAMLIN:
Q. Doctor, can you tell us what this statistical
model is.
A. Can I just come down here? It will be easier.
This is just a -- a simple what -- what we call
in the jargon a
two-by-two table. It's not a very complicated thing. It's two because
there
are two rows and two columns, two by two. And -- and it's a statistical
model in the sense that it has quantitative information, numbers, you
see
here 25. That helps us understand how in this case the time needed
to drive
to the airport depends on some factors that we might want to take into
account when we're planning our trip to the airport; namely, where
are you
leaving from, either downtown Minneapolis or here at the courtroom
in
downtown St. Paul, and when are you leaving, either going at mid-day
when
it's not rush-hour, or traveling during rush-hour. And what this table
shows is the average time it takes to get from each of these locations,
here downtown Minneapolis at mid-day, 25 minutes. Okay? And downtown
St.
Paul at mid-day, 15 minutes. It takes less time. And during rush-hour,
downtown Minneapolis to the airport, 45 minutes. So it's 25 -- 20 minutes
longer during rush-hour than during mid-day, and from downtown, 35
minutes
during rush-hour, again, 20 minutes longer.
So this is an example of using quantitative information
to address a
question how long does it typically take to get to the airport. And
we have
two factors, where are you leaving from, and what time are you leaving,
that we might take into account when we plan a trip to the airport.
*31 Now all of us go to the airport all the time
to pick up a friend or
perhaps we work out there or perhaps we are even lucky enough to take
a
flight, and when we think about when we're going to leave for the airport,
we all go through these sorts of calculations. We all sort of think,
well,
I'm going to be downtown in Minneapolis, so I better leave a little
longer,
and I'm not going to be able to get out until 4:00 o'clock, so I need
to
leave longer yet. So we're -- we're -- we're always thinking about
how a
particular outcome, here time to the airport, depends upon factors
which we
think may influence it.
This is just an example of a statistical model.
It's a tool. It isn't
exactly right. You don't always take 15 minutes. Although when I --
I got
this table, consulting some of the local experts, and when I did come
from
the airport a couple days ago, I did take exactly 15 minutes from the
airport to downtown St. Paul.
THE COURT: Was that in a cab?
(Laughter.)
THE WITNESS: It was in a cab, yes. It took me 15
minutes to get the
cab.
A. So it isn't always that way. Sometimes it's a
little bit longer,
sometime it's a little bit more. And there are certainly other factors
that
aren't listed here. I mean a truck that's, you know, broken down in
the
right- hand lane, there are some factors that can also influence which
aren't here. Nevertheless, this is -- this is a useful -- useful thing
to
know. If I had never been to this area and needed to plan a trip to
the
airport, I would certainly start here.
And the other point about this little example, it's
an example of a
statistical model, it has quantitative information and how that
quantitative information depends on factors, but it's something we
always
do. All of us do it every day. And I've just chosen one example, but
if you
think in your own mind, there are many others ------ information and
make
decisions using that information and how that information depends on
certain factors.
Q. Now can this statistical model also be expressed
as a formula?
A. Yes.
Q. And have you prepared an exhibit showing that
that -- that formula?
A. Yes, I have.
Q. I'd like you to turn to Trial Exhibit 30175,
and is that entitled
"Statistical Models can be Expressed as Formulas?"
A. Yes, it is.
Q. It was prepared at your direction?
A. Yes.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit
30175 for
illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30175.
MR. HAMLIN: Can we have that on the Elmo, please.
BY MR. HAMLIN:
Q. Doctor, could you tell us what we see on this
exhibit?
A. Yes. This -- the purpose of preparing this exhibit
is to show that
that information which we were just looking at, the kind of information
we
use every day that helps us make decisions, that information can be
expressed not only in a little table but also as a formula, and this
is an
illustration just to make that point.
*32 So what's now displayed on the Elmo is the original
table with the
-- the numbers we've already talked about, the times to the airport,
and
I've just rewritten those four numbers, 25, 50, 45, 35, in a formula.
Okay?
Let's just see. And sometimes it's a little bit off-putting, but let's
just
see what it says.
The formula says if you want to know the time in
minutes to the
airport, what you should do is start with 15 minutes. Okay? But if
you're
going from downtown Minneapolis you should add 10 minutes, and if you're
going during rush-hour you should add 20 minutes.
So let's see if this formula works. And it's --
all a formula means is
it has a left-hand side, the thing you're interested in, time in minutes,
and that says that equals some factors. All right? And you just add
up the
numbers to get what you -- to get the -- the value of interest. So
let's
see if the formula works. Let's start by a trip from St. Paul during
mid-day. We know that takes an average 15 minutes according to this
table.
So the formula says the time is 15 minutes, add 10 if you're going
from
Minneapolis. Well we're not going from Minneapolis, we're going from
St.
Paul, so don't add 10. Okay? And if you're going during rush-hour,
add 20.
Well we're not going during rush- hour, we're going to mid-day, so
we are
not going to add 20, so we end up with 15. To the formula reproduces
the 15
in the table.
What if we want to go from downtown Minneapolis
during the day? We
start with 15. It says add 10 if you're in downtown Minneapolis, so
yes, it
is. So we add 10, we get 25. Are we going during rush-hour? No. So
we don't
do that. So we end up with 15, plus 10, which is 25, so that's exactly
what
the table says.
Let's just do one more to make sure we get that
right. Let's do
downtown Minneapolis during rush-hour. It says 15 plus 10 from Minneapolis,
well it is, so that's 25, plus 20 if during rush-hour, it is rush-hour,
so
we have 15 plus 10 plus 20 which is 45, which is exactly what the table
says.
Trust me, it works for the last one as well.
So this is just an example of taking the information
in the table,
which describes how time to the airport depends on some factors, where
you
leave from and what time you go, and putting it in terms of a formula.
And
formulas are convenient because they're the kinds -- that's -- that's
--
that's what we can use if we want to make more complicated calculations
with -- with more factors that we want to take into account, and they're
also desirable because we can do our computing in -- we can do our
calculations using computers if we can make these tables into formulas.
And here just to illustrate the idea of taking something
else into
account, we have another -- we're adding another four minutes or every
inch
of snow in the previous 24 hours, so that might be an example of another
factor that you might use to refine your estimate of time to the airport.
Q. Doctor, what if any relationship do statistical
models have to the
real- world events that they purport to measure?
*33 A. Well statistical models are -- are tools
for calculating
quantities of interest in a -- in those things we're interested --
those
quantities we're interested. So here was an example of -- of a statistical
model that would help us make a decision about going -- going to the
airport at the appropriate time.
Q. Are these models perfect --
A. No.
Q. -- in terms of their predictive ability?
A. No. Obviously everybody understands that the
time it takes you to
get to the airport varies. You can't predict it exactly. On the other
hand,
this is an approximation and it's useful. That's -- that's the thing.
If I
were -- if -- if I were to come to town now knowing the area and had
to
plan a cab trip to the airport and I said to something I'm going to
be
leaving from downtown St. Paul, it's not going to be rush-hour, and
they
said well gee, I can't tell you because I don't know whether there's
a pot
hole out in the highway and I don't know whether such a road has, your
know, been closed last week and I don't know if it's wet. They tell
you all
the many, many things that, yes, do influence the time to the airport.
Well
that wouldn't be very helpful to me. If they gave me, you know, their
best
estimate based upon perhaps their -- their real experience, that would
be
helpful.
So the point is models are approximations. They're
not exactly true.
But they're useful, and we rely upon them every day for decisions we
all
make.
Q. Dr. Zeger, were you retained in this case to
estimate the amount of
health-care costs paid by the state of Minnesota and Blue Cross Blue
Shield
of Minnesota to treat diseases and conditions caused by smoking, made
worse
by smoking, or made more expensive to treat by smoking?
A. Yes, I was.
Q. And what was the time period that you were asked
to assess?
A. From 1978 to 1996.
Q. Now what are these health-care costs called?
A. We call them smoking-attributable expenditures.
Smoking-attributable
expenditures.
Q. Have you reviewed the trial testimony of Dr.
Jonathan Samet in this
case?
A. Yes.
Q. And are you relying on it, in part, for your
opinions in this case?
A. Yes.
Q. What if any information has Dr. Samet provided
to you regarding this
definition of smoking-attributable expenditures?
Perhaps you could use the flip chart to answer that
question, with the
court's permission.
A. This problem is an example of a public health
problem. And as I
illustrated, I think, with the previous comments, in order to work
effectively on a public health problem, you need a collaborative team,
and
you need experts certainly in public health as well as in -- in statistical
modeling. And so -- excuse me.
So in order to estimate smoking-attributable expenditures,
which I'll
abbreviate if you don't mind --
Q. And what do you mean by "expenditures?"
A. Dollars, basically, dollars expended for smoking-attributable
treatment.
In order to estimate this, you need to -- you need
to start with a -- a
medical model for how the world works, and that's what Dr. Samet provided
us. And basically it was that smoking causes disease, and disease results
-- excuse me, disease results in expenditures, in additional expenditures.
*34 Q. Thank you.
Did you work with others in this project, Professor
Zeger?
A. Yes.
Q. And -- and with whom did you work?
A. Well in addition to Dr. Samet, I worked with
two others, Dr. Len
Miller, who's a health economist at the University of California at
Berkeley, and also with Dr. Timothy Wyant, who's a Ph.D. biostatistician
trained at Johns Hopkins University.
Q. Now what was Dr. Samet's role in this effort?
A. Well Dr. Samet, as I said, he was the medical
expert in our team. He
laid the medical foundation for everything we did. And I basically
described it there, that smoking causes disease, which results in
additional expenditures. So that -- that was the first thing. He --
he
built the -- you could think he laid the foundation on which we built
our
calculations.
Q. Did he provide screens as well?
A. Yes.
Q. Could you tell us about that.
A. Yes. As -- as I'll describe, we -- we used enormous
amounts of
information on health-care expenditures for citizens of Minnesota,
and Dr.
Samet helped us assure that the people we identified as -- as having
smoking- attributable diseases actually had those diseases.
Q. And did Dr. Samet provide you with the conceptual
structure of the
model?
A. Yes, that's -- that's what I -- that's really
what I described here.
We built the model on a framework which says smoking causes disease
which
results in expenditures, and so we focused on data for smoking, disease
and
expenditures.
Q. And did Dr. Samet discuss with you studies in
epidemiology?
A. Yes. As I said, in order to be effective in a
-- in a research
project like this, one needs a collaborative team, and Dr. Samet
represented the epidemiologic and medical expertise that we relied
on as we
had to make decisions about the statistical modeling.
Q. Did Dr. Samet discuss with you possible confounders?
A. Yes. We -- we had numerous conversations about
that and other issues
in epidemiology, other epidemiologic issues.
Q. Did Dr. Samet recommend to you any specific statistical
methods to
be used in the model?
A. No.
Q. What was Dr. Miller's role?
A. Well Dr. Miller is a health economist, and --
and he has
considerable expertise in the study of the health effects of smoking.
He's
the author of the United States government's Center for Disease Control,
that's the CDC, Study on Smoking and Health Expenditures, and so he
-- his
expertise was from an economics, health economics perspective. He also,
along with Dr. Wyant, did some of the -- most of the computing in the
project.
Q. What was Dr. Wyant's role?
A. Well Dr. Wyant is a Ph.D. biostatistician with
considerable
expertise in using complex data sets, big, large data sets and putting
them
together in order to be able to effectively address a question like
this
one. So he -- he took responsibility for the data sets and for much
of the
computing in the -- in the project. He's also an expert biostatistician
with experience in -- in claims cases like this from previous experience
in
cases like this.
*35 Q. And what was your role, Professor Zeger?
A. My role was, again, as a collaborator with the
other three, helping
make decisions about the direction for the project. I worked on all
aspects
and focused quite considerably on what we have called the core model
which
we'll talk about.
I also, I would say, had responsibility for -- because
of my background
in the application of statistical methods to public health, for ensuring
that we were using appropriate statistical methods when we did the
model.
Q. Are we going to talk about the core model in
a moment?
A. Yes.
Q. Doctor, how long have you worked --
Professor, how long have you worked on this project?
A. I think it's been about 18 months. My participation
has been about
18 months.
Q. Have you attended meetings?
A. Yes. Many, many meetings, hundreds of -- perhaps
a hundred meetings.
Q. Have you had discussions with Drs. Samet, Miller
and Wyant regarding
this model?
A. Yes. Ongoing, extensive discussions.
Q. Is this an example of the type of collaborative
effort that you have
previously testified about?
A. Yes. This has gone exactly the way other collaborations
I have
described go with different expertise brought to the table where we
worked
together on trying to solve a problem.
Q. In developing plaintiffs' statistical model,
did you follow commonly
practiced biostatistical principles?
A. Yes.
Q. And can you tell us what those are.
A. Well the first one is already illustrated on
the board. The first
principle which we followed was to try to start with a foundation in
health, not to work, you know, in a vacuum as statisticians, but rather
to
work with an understanding of what the health process is by which there
might be additional expenditures. And Dr. Samet really provided that
to us,
and it's drawn there on the board. It's what --
The reason there might be additional expenditures
is because smoking
causes disease, and it's the disease that causes money -- it causes
us to
have additional expenditures or results in additional expenditures.
Q. What other biostatistical principles did you
follow?
A. Well, having a framework like this, we then would
ask what's the
best available information in order to look at -- at how smoking causes
disease which results in expenditures, and we went out and identified
the
best possible information to do this project. And in this case, the
thing
right in the middle of those three steps is disease, and what we were
able
to do was to go and actually get some 280 million doctors' bills records.
Basically, these are claims records from the state and from Blue Cross
Blue
Shield, and these records have on them the diseases that Minnesotans
had
over the period of time we were studying, as well as the dollars expended
to treat those diseases, as well as some other information about the
people. And so -- and -- and I -- and that was an enormous, you know,
effort, but also very valuable information in order to be able to look
at
what the health -- what -- what the smoking- attributable expenditures
were.
*36 Q. You used the term "claim record." What do
you mean?
A. My understanding of the claim record is that
when -- when a doctor
files a bill to be paid for the state or for Blue Cross Blue Shield,
you
know, there -- there's a record kept of the bill with the information
that
I described, and these 280 million records are largely listings of
every
claim that was made by a doctor or by another provider for services
rendered.
Q. And are these records kept by the state of Minnesota?
A. Yes.
Q. And are these records kept by -- or are there
different records kept
by Blue Cross Blue Shield of Minnesota?
A. Yes. Both the state and their programs, the Medicaid
program and in
the General Assistance Medical Care program, both of those are programs
for
people who are poor, to provide medical care for people who are poor,
they
-- they keep detailed records of every expenditure that they made and
--
and what the disease was and what treatment was provided, the dates
and so
forth. And Blue Cross Blue Shield does the same thing.
Q. And did the claims records at Blue Cross Blue
Shield cover any
particular plans?
A. Yes. Blue Cross Blue Shield has what are called
group plans where if
you work for a company and the company wants to be insured, medically
insured with Blue Cross Blue Shield, they would cover all the employees
of
the company, and so it was for those kinds of plans that we had
information.
Q. So these were the claims records that were collected.
A. Yes.
Q. Now can you tell us essentially what's on a claim
record?
A. Yes. A claims record has a date of certain --
it has a person I.D.,
a name. We didn't get the names. But it had a person I.D., an
identification -- an identifier for a person, it has what service was
rendered, what disease the service was for, what's called an international
-- an IDC-9 code -- ICD-9 code, international classification of Disease
code, which is basically indicating what sort of treatment it was for
what
sort of disease it was. And then the kind of service that was provided
and
then the dollars expended. And it also has some information about the
person, it has their -- their age and their gender, and in some cases
it
has some more information about them, marital status, I think, is an
example.
Q. Do the claims records include any information
about smoking?
A. No.
Q. And that's true for the state of Minnesota?
A. Yes.
Q. It's also true for Blue Cross Blue Shield?
A. There's no smoking information on the medical
claims records.
Q. Did we obtain smoking information about Minnesotans?
A. Yes, we did.
Q. Where?
A. So -- so the first data set we got was the 280
million claims
records. There's another data set called the Behavioral Risk Factor
Surveillance System, or BRFSS, B-R-F-S-S, Behavioral Risk Factor
Surveillance System.
Q. Could you tell us about that --
A. Yes.
Q. -- survey.
A. This is a -- an ongoing survey that's run by
the Department of
Health for the state, and it's actually a survey that's done by many
states
coordinated -- coordinated by the federal Centers for Disease Control.
And
this is a survey of health behaviors, and so it has information, for
example, about whether people smoke or not, and then much -- considerable
other pieces of information about the person's health behaviors. So
we were
able to get over an 11-year period, I think it was, 1984 to 1994, some
35,000 records on citizens of Minnesota indicating information about
their
health behaviors, in particular their smoking, whether they smoked
or not.
*37 Q. Did we obtain information from any other
surveys or sources of
data?
A. Yes. There was one other large source which I
want to mention now
which was in order -- which we needed in order to understand the
relationship between smoking and disease, so there's -- there's a study
called the National Medical Expenditure Survey, or NMES, NMES, the
National
Medical Expenditure Survey.
Q. Can you tell us about that survey.
A. Yes. This is a survey that is done every 10 years
by the federal
government, the last one was done in 1987, and they're going to be
-- I
think they're starting one soon. There's one in the field now. And
this is
a study that's done -- survey that's done in order to identify factors
which influence expenditures on health care. So we -- we were able
to
obtain data from the National Medical Expenditure Survey, the one in
1987,
originally through a sample of some, I think, 28,000 people around
the
country, and we -- we have used that data as well.
Q. And what kinds of information is on -- is in
that data?
A. Right. Well the National Medical Expenditures
Survey is the one
place where we actually have information about all the steps in our
medical
foundation. We have information about whether people smoke or not,
we -- we
have information about what diseases they have, and we have information
about how many dollars were spent to treat their diseases.
Q. Professor Zeger, did you use any other principles
of biostatistics
in preparing the statistical model in this case?
A. Yes, we did. So the first principle we -- we
used was to start with
a medical model, smoking causes disease which results in expenditures,
then
we went out and found -- with that model we went out and found the
best
data for expenditures, disease and smoking. And -- and -- and we found
considerable amounts of -- of data for each of those.
Then the next question is: How should we organize
the estimation of the
smoking-attributable expenditures? How should we go about trying to
estimate those dollars? And so --
Q. With the court's permission, could you come down
and show us on the
flip chart how you went about organizing those dollars.
A. Okay. Thank you.
So we basically broke the problem up into some parts
that we could --
each of which we could manage more directly, and the way we broke it
up
really was dictated by this medical underpinning to our approach given
to
us by Dr. Samet. And there are dollars expended for all kinds of things,
and what we did is we classified those dollars by what I'll call disease
or
conditions.
So let's just start -- what we first did is we broke
the problem into
looking at the expenditures for medical services, medical services,
and --
and I'm distinguishing medical services from the other kind of services,
which were in order to maintain people in nursing homes. The state
spends
money for persons who are -- are poor and go into nursing homes, and
these
fees are not to provide medical care to them in the nursing homes,
but only
to pay their residence fees. So we decided, given smoking causes disease
which -- which results in dollars, to treat the -- the medical expenditures
separately from expenditures for maintaining people in nursing homes.
Okay?
*38 And then if we look at the medical expenditures,
we further broke
that into two pieces. Okay? There -- there are two kinds of medical
expenditures, and again it keys off of Dr. Samet's model. We -- we
focus on
the diseases, and we broke it into a part that had to do with the major
smoking- attributable diseases, and to another group of diseases or
conditions which Dr. Samet has called diminished health. And then we
further broke up the major diseases into two groups, lung cancer and
chronic obstructive pulmonary disease, or COPD. And then all -- all
of the
remaining, there are 10 others that were identified by Dr. Samet, and
since
the most common ones are coronary heart disease and stroke, we'll call
that
group CHD/stroke, but I'll put a little plus there to indicate that
there
are other conditions as well in that group.
Q. Professor Zeger, let me stop you there. Could
we have on the Elmo
Trial Exhibit 30153, which has been previously admitted into evidence,
Your
Honor, and could you identify for us what that exhibit is?
A. Yes. This is a listing of the ICD-9 codes, the
International
Classification of Diseases, 9th Revision for ICD-9, and these numbers
here,
440-441, 444 and so forth, those are the ICD-9 codes, and these were
identified by Dr. Samet. It's basically a listing of the diseases which
we
call the major smoking-attributable diseases. And also it's listed
here
diminished health at the bottom, which is not one of what we call the
major
smoking-attributable diseases.
Q. Now was this list of diseases provided to you
by Dr. Samet?
A. Yes.
Q. Did you have any involvement in the preparation
of this list?
A. No.
Q. Now could you tell us which diseases are in the
first portion of
major smoking-attributable diseases marked lung cancer, COPD, using
the
ICD-9 code list?
A. Let's see if I can find it. Here's lung cancer.
Q. Right.
A. ICD-9 code 162. And chronic obstructive pulmonary
disease is right
here, COPD, and there's a couple of codes for that one.
Q. And could you identify for us the diseases in
the CHD/stroke
category of the model.
A. Yes. It's all the other major diseases identified
by Dr. Samet, so
let me just quickly go through them. Atherosclerosis, bladder cancer,
cerebrovascular disease, coronary heart disease, esophageal cancer,
kidney
cancer, laryngeal cancer, oral cancer, pancreatic cancer, and peptic
ulcer
disease. Those are the ones that we're calling CHD/stroke -- the CHD/stroke
group.
Q. Thank you.
A. And then just -- just to make this point, this
diminished health is
the last entry, this is not a major smoking -- not a major
smoking-attributable disease, but it's the last category that we've
--
we've divided the problem into.
Q. Professor Zeger, did you use any other biostatistical
principles in
developing the plaintiffs' model in this case?
A. Yes, there was one other I want to mention, which
is, as with any
large problem, we have -- we have a medical foundation, we went out
and
found the best data, and we've tried to break the problem into sensible
parts that we could attack. But the other thing that's useful to do
is to
try to not only go at sort of the whole big solution, but, you know
-- or
the complex solution, but to also build sort of a simple model, one
that's
easy to understand, one that's easy to explain, and -- and so I would
call
the principle of trying to take a simple approach as well as a refined
approach to estimating smoking- attributable expenditures, and that's
what
we've done.
*39 Q. What did you call the simple approach?
A. I've called it the core model. The core model.
And I called it core
model because our purpose was in trying to build some simpler calculations.
These -- these don't have all the bells and whistles on them, but they're
the core, they're the heart of what happens in the refined model. So
we
have this refined model and a core model which is simpler, but we
purposefully designed the core model to allow us -- allow us as the
statisticians and medical scientists to understand what -- what's going
on
at the core of the calculation, how the calculations are actually being
made, so that we would have confidence that the refined model was doing
the
right thing. And it also has the very valuable purpose, so that you
can
explain it to other people. So that when we look at what the core model
does, that's exactly what's happening in the full refined model, but
-- but
the core model has been designed so you can explain it clearly and
you can
see what's going on clearly so you'll understand what's happening in
the
refined model better. And I must say that the goal is for us to understand
ourselves first, and then to be able to explain it to other people
accurately.
Q. Now you worked on both the core and the refined
models?
A. Yes, I did.
Q. Have you followed this principle in your work
apart from this case?
A. Yes.
Q. I mean is --
A. I try in most of my projects, especially if they
become complex, to
try to look at what's at the heart of what's going on in the complex
work
by creating sort of a simple version of it to see that -- how these
things
fit together.
Q. What diseases did you examine in the core model?
A. The core model only looks at the major smoking-attributable
diseases. So in the core model we looked at lung cancer, COPD, and
we
looked at the CHD/stroke group, which includes all of the other major
smoking-attributable diseases.
Q. Did you address in the core model diminished
health?
A. No.
Q. Did you address in the -- in the core model nursing
home residence
fees?
A. No.
Q. Why did you focus on the major smoking-attributable
diseases?
A. I thought that would be the group of diseases
where it would be
easiest to see what was going on with our modeling effort where --
where
the core model would be most valuable.
Q. Can we turn now to how the core model works.
How do you identify
people with major smoking-attributable diseases?
A. Well we're very fortunate that we have these
medical claims records.
So as I said, we have some 280 million records, and on each record
that is
describing a doctor's visit, for example, there is an ICD-9 code of
what --
what was done -- what -- what the visit was about. So you can see the
codes
up there again. And what we basically did is we searched all of the
records, these millions of records, to identify Minnesotans who were
suffering from one of those major smoking-attributable diseases, and
we
uncovered more than 90,000 people in the period of time for which we
had
the records.
*40 Q. What did you do next?
A. So we had all of the medical records for these
90,000 people from
Minnesota who had these diseases caused by smoking, and the next step,
then, was to go through and for each of the persons find all of their
expenditures so that we would know in a given year how many dollars
were
expended on a particular person who had lung -- lung cancer, for example,
or chronic obstructive pulmonary disease.
Q. And did you total all these lung cancer dollars?
A. Yes. We were able to then total all the dollars
for medical services
provided to all the Minnesotans who had lung cancer, for example.
Q. Is that the smoking-attributable expenditure?
A. No, that's -- that's not it. That's the total
dollars that were --
was expended for their treatment, not the dollars that were attributable
to
their smoking.
Q. And what did you do next?
A. Well what we did is we built a system for taking
these total
dollars, which again come from the medical claims data, these are the
real
dollars expended for the real citizens of Minnesota who had these diseases
that Dr. Samet had indicated were caused by smoking. And again, I just
want
to make the point that it's using his -- his model, smoking causes
the
diseases. We're targeting in on the diseases he identified for us.
We totaled up the expenditures for these people
and then we applied a
series of reductions, because we don't want to take all the dollars
expended for them as being the ones that are attributable to their
smoking,
we only want to take a certain part of those expenditures.
Q. And have you prepared an exhibit showing those
three reductions?
A. Yes, I have.
Q. Can you turn to Trial Exhibit 30197. Can you
identify that, please.
A. Yes. This is the display that I've created called
the core
statistical model, three reductions.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit
30197 for
illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30197 for illustrative
purposes.
BY MR. HAMLIN:
Q. Professor Zeger, I'm going to put the exhibit
up on the easel, and
with the court's permission, I'd ask you to come down and could you
tell us
what is on this exhibit.
A. So let me -- let me just review where we were.
We've got all these
billing claims records, Minnesota claims records. We go through, we
find
all the people, more than 90,000, who are suffering from lung cancer,
COPD,
and the other major smoking-attributable diseases identified by Dr.
Samet.
For each of those people we sum up the total dollars expended by the
state
or Blue Cross Blue Shield to take care of them. Okay? And that's where
we
start at the top of this chart. We have the total dollars that was
expended
on a person who had -- we knew they had a major smoking-attributable
disease. So that's our starting place.
And then what we do is we take those dollars and
we reduce those
dollars three times. And what I want to do is give an overview, first,
of
why it is we make these reductions.
*41 The total dollars expended for these people,
those dollars weren't
all caused by their smoking. This is the total dollars expended. There
may
be dollars in there for things having nothing to do with their smoking.
So
we have to reduce these dollars. And here's how we do it. The first
reduction, which we call what percentage are smokers -- now I've already
told you the claims data doesn't include information about whether
somebody
smokes. It's not available. So we have some 90,000 people who we know
have
diseases that are caused by smoking, but we don't know whether that
person
in particular is a smoker. So what we do is we get information from
another
source, the National Medical Expenditure Survey, and we determine the
percentage of persons who have that disease. Let's take lung cancer
for
example. We take -- we -- we determine the fraction of persons who
have
lung cancer who are smokers. Okay? So we have this pool of dollars
that's
been expended to treat people with lung cancer. We know lung cancer
causes
-- is caused by smoking, so what we do is we reduce the total dollars
by
the fraction of persons who are smokers. We only take the dollars for
the
persons -- for the fraction of people who smoke, for the -- for the
percentage of people who smoke. And in making that first reduction,
what
we're basically doing is setting aside dollars that have been expended
for
persons who aren't smokers. Okay? So that's the first reduction, what
percentage are smokers.
Then we -- what we end up with at the end of the
first reduction is the
total dollars expended for persons who have lung cancer who are smokers.
Okay? And we have an estimate of that.
Now we're going to reduce it a second time. Why
would we -- why would
we reduce it a second time? Because we recognize that some proportion
of
people who are smokers who end up with lung cancer, they might have
gotten
lung cancer even if they hadn't been a smoker. In the case of lung
cancer,
nearly all lung cancer cases, people are smokers, but it is possible
to get
lung cancer if you're not a smoker. You've heard that. So what we want
to
do is set aside those dollars that -- that -- for people who have lung
cancer and who -- and who smoke, but where we think that a fraction
of them
wouldn't have -- would -- would have had lung cancer even if they hadn't
smoked. So that's the second reduction, what percentage of smokers'
disease
is attributable to smoking.
Now what we end up with at the end of the second
reduction is a pool of
dollars that is for smokers whose lung cancer -- or whose disease was
caused by their smoking. We've set aside the non-smokers, we've set
aside
the dollars for diseases that would have occurred anyway even if the
person
hadn't smoked, and now we still have one more reduction to go. And
that's
because at this point we still have dollars in the pool for treatment
of
conditions which aren't related to the smoking. I mean, you know, if
you
have lung cancer, you might also have other things happen to you; you
might
fall down and break your leg and it might have nothing to do with the
lung
cancer.
*42 So at this point we still have the total dollars.
The third
reduction says what dollar percentage is attributable to the particular
smoking-caused disease? So we want to set aside things that aren't
attributable to that disease.
So what we do is we start at the top of the chart
with the total
dollars expended to treat Minnesotans who have diseases that are caused
by
smoking, and we reduce it three times to -- to eliminate the non-smokers,
to eliminate the disease that would have occurred even if the persons
hadn't been smokers, and then finally eliminate the expenditures for
services that were unrelated to the particular disease we're looking
at.
And what we get at the end of these three reductions, we start with
total
dollars, and what we get at the end is what we're calling
smoking-attributable dollars.
Q. Now can you give us an example of how these reductions
work, and
specifically, have you prepared a board?
A. Yes, I've prepared one board for each of these
reductions.
Q. All right. Now let me -- let me show you the
board first. I want to
show you Trial Exhibit 30198. And was this board prepared at your
direction?
A. Yes, it was.
Q. And is this a hypothetical example for ten thousand
Minnesotans?
A. Yes, it is.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit
30198 for
illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30198 for illustrative
purposes.
BY MR. HAMLIN:
Q. Professor Zeger, we'll put the board on the easel,
and if we could
have the previous exhibit up on the Elmo.
Can you tell us what Trial Exhibit 30198 is.
A. Well what I've done is I've created a hypothetical
population of
people, ten thousand Minnesotans, in order for us to actually go through
what the calculations are to see if they're reasonable. And this is
the
idea of core model, to help us understand that what we're doing is
sensible. So this is a hypothetical example of ten thousand Minnesotans.
Okay? And what we've done is we've made what -- what I previously called
a
two-by-two table, two rows and two columns, and then a total. We won't
count that one. So we have ten thousand people indicated here, and
what
this table shows is that five thousand of the ten thousand are smokers.
Okay? And another five thousand are never smokers.
Now when I use the word "smokers," I'm going to
include people who are
currently smokers, currently smoking, and people who are former smokers
as
well. So I'm distinguishing ever smoker from never smoker. Okay?
So I have five thousand smokers and five thousand
never smokers in my
hypothetical population of ten thousand people. Okay? Now what else
do we
-- what other information do we have in this table in this model? We
have
whether the person has lung cancer or not. Okay? So if we looked at
the
smokers, there are 5,000 smokers, how many have lung cancer? 140. Okay?
And
how many don't have lung cancer? Well the remainder, 4,860 don't have
lung
cancer.
*43 Now let's look at the never smokers. Again,
there are 5,000 of them
in total. How many of them have lung cancer? Twenty of them. Okay?
And how
many don't have lung cancer? The remainder. Okay? And how many lung
cancers
are there in total? Well there's 140 lung cancers among the smokers
and 20
lung cancers among the people who didn't smoke, so there's a total
of 160
people who have lung cancer in this hypothetical population. Okay?
Q. And then could you go on with the example.
A. Yes. So what we now want to do is we want to
look at the first
reduction. The first reduction says we only want to take money for
the
percentage of people who are smokers. You see what we get in our --
from
our claims records is we identify these 160 people, we search all the
claims and we're able to find out that 160 people have lung cancer.
Okay?
But we don't know -- we don't know whether they're a smoker or not
from the
Minnesota claims data. Okay? So what do we -- what do we need to do
to take
this 160? Do we want to take -- make -- make all the dollars expended
for
them and say that's due to smoking? No, that wouldn't be fair to do
that.
Okay? Do we want -- do -- is it fair to get the money for these never
smokers, these 20 never smokers? No. Smoking clearly didn't cause their
disease.
Okay. So the first reduction says of the 160 people
who have lung
cancer, what percentage of them are smokers? Okay? Well we have the
information we need here. We see 140 people are smokers out of a total
of
160. So that's how we do the first reduction. And we can actually look
at
that.
Q. Do you --
Have you prepared a board showing the calculation
for the first
reduction?
A. Yes, I have.
Q. All right. And --
A. If we put it up there, I think it will be helpful.
Q. Actually, I think -- why don't you go back and
identify it first and
then we'll put it up.
I want you to turn to Trial Exhibit 30191.
A. Yes.
Q. Is that the board or the exhibit that you prepared
showing the first
reduction calculation?
A. Yes, it is.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit
30191 for
illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30191 for illustrative
purposes.
Q. You've got the exhibit now on the Elmo. Could
you explain that.
A. Yes. So just to recap, we -- we started with
all the dollars, with
160 people who had lung cancer, and now we're trying to work our way
towards the percentage of dollars which you could attribute to their
smoking.
Well clearly you can't attribute to smoking the
dollars spent for
people who didn't smoke. All right? So what we need to know is the
fraction
of dollars, the percentage of dollars that was for smokers. Okay? Well
here
we have the information in the table we need, and this was the standard
practice in statistical analyses, we see that of the people who have
lung
cancer, the 160 people, 140 of them are smokers and 20 were not. So
how do
we reduce the 160 down to 140? Because we shouldn't take money for
these 20
persons. You simply calculate a percentage which is 140 out of 160,
or 87.5
percent. And that's what we call the first reduction percentage. And
if you
take 87.5 percent of 160 people, you get 140 people. Okay?
*44 So at the end of the first reduction, what we've
done is we've
taken all of the people with lung cancer and we've estimated the fraction
-- estimated the -- the number that -- that are smokers. Okay. We start
with 160, we multiply 160 by the first reduction percentage, 87.5,
and we
end up with just the smokers, 140.
Q. Go ahead and go back.
MR. HAMLIN: Your Honor, this may be a good time
to break.
THE COURT: All right. We'll recess, reconvene tomorrow
morning at 9:30.
(Recess taken.)